Device evidence · October 31, 2026
Read the scope behind a 510(k) number.
A number can lead to the right FDA file while the quoted model or use still differs. Compare the record, the indications and the supplier’s exact item before treating them as a match.
Keep two columns of evidence
The FDA file and the quoted item are separate.
Start in the FDA 510(k) database with the supplied K-number. Open the decision and the available summary documents. Record the actual field values; do not fill missing model details from a shared brand name.
- Number and decision
- FDA fileK-number, decision date and decision description.
- Supplier evidenceThe exact reference claimed. A K-number is not an FEI, and a received date is not the decision date.
- Device and model
- FDA fileTrade/device name and the models or versions described in the summary and labeling.
- Supplier evidenceModel, catalog number and software version on the quotation or label. If the connection is absent, record it as unresolved.
- Indications and users
- FDA filePurpose, patient population and prescription/over-the-counter use in the Indications for Use document.
- Supplier evidenceThe use being advertised, intended users and population. Keep restrictions with the claim instead of quoting only the device name.
- Applicant and predicate
- FDA fileApplicant for this submission; predicate device used for the comparison.
- Supplier evidenceHow the seller and quoted item relate to the applicant. The predicate’s name or number is not the subject device’s clearance.
No downloadable summary? Check whether the record says “Summary” or “Statement.” Keep an unavailable document as a gap. A missing download or failed source does not establish that a device is uncleared.
One historical FDA record · not a supplier assessment
K232023: a name match still needs a scope check.
This example uses the published record for Momentum Spine. It does not verify a current seller, current labeling or a product offered for sale today.
Read the population, not just the name.
The published Indications for Use describes an optical contour sensing mobile application for quantifying asymmetries, assessing body angles and curve progression related to postural asymmetries, including scoliosis. It states patients 8 years and older and describes both over-the-counter availability and use prescribed by physicians.
The Summary’s device description says a mobile-device video is used to reconstruct a 3D torso model. Its stated purpose is not, by itself, evidence for every diagnostic or treatment claim a seller might make.
“Momentum Spine for children of any age”
The name matches the example record, but the quotation does not specify a software version and expands the age range.
Identity and age range still need evidence.
Keep the supplier’s exact wording. Request the version/model connection and applicable labeling that supports the offered population. Do not replace “8 years and older” with “any age.”
Geography matters: this is one U.S. FDA-market decision with a Canadian applicant. The applicant’s country does not turn it into a Canadian authorization or worldwide approval. One record is not a count of manufacturers, sales or market size.
Leave an evidence trail
Write a comparison someone else can repeat.
- Save the official record and document URLs, K-number, decision date and retrieval date.
- Quote the relevant indication and identify the page or section: “Indications for Use,” “Subject Device” or “Device Description.”
- Keep the seller’s model/version and claim beside the record wording. Mark each missing connection explicitly.
- Recheck current labeling and later relevant records before relying on a historical summary. A substantial-equivalence decision is not a supplier endorsement.
Use the supplier evidence worksheet for the complete packet. Check recall notices and affected-item identifiers separately; this guide does not perform that check.
Primary sources
Source, date and limits stay together.
- FDA K232023 decision, Indications for Use and 510(k) Summary (PDF) — decision October 4, 2023; see Indications for Use and Summary sections 2, 4 and 5.
- openFDA: the K232023 record — one historical decision; snapshot October 19, 2026. Used for number, name, applicant, country, date and decision fields.
- FDA: Content of a 510(k) — document structure and field meanings, not sector statistics.
Consulted October 31, 2026. The PDF and FDA guidance were read through a text representation; the openFDA record was queried directly. This is a reading example, not a fresh FDA decision or verification of a current supplier. Unavailable details remain unresolved.