Stuart: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Stuart” (first 1982, latest 1990), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 80 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 2 | 2 |
| EZX | Mesh, Surgical, Metal | 1 | 1 |
| JDN | Implant, Fixation Device, Spinal | 1 | 1 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 1 | 1 |
Review panels
Most recent Stuart 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K897141 | SLOT STAPLES AND ADAPTOR FOR ZIELKE SPINAL FIXATIO | JDN | 1990-06-21 | 176 |
| K890601 | STUART TITANIUM SURGICAL MESH | EZX | 1989-03-16 | 38 |
| K851414 | SEGMENTAL SPINAL RODS | KWQ | 1985-06-28 | 80 |
| K843445 | SACRAL BAR | KWP | 1985-02-13 | 161 |
| K820034 | ANTERIOR DISTRACTION SYSTEM | KWQ | 1982-03-11 | 66 |
Recalls
openFDA lists no recalls under a recalling firm named Stuart.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Stuart Drug & Surgical Supply, Inc. (2 510(k)s)
- Stuart Medical, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Stuart?
FDA lists 5 510(k) clearances under the applicant name “Stuart” (first 1982, latest 1990), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Stuart?
The median time from FDA receipt to decision across 510(k)s cleared under the name Stuart is 80 days.
Which FDA product codes appear under Stuart?
The most frequent FDA product codes under this applicant name are KWQ (Appliance, Fixation, Spinal Intervertebral Body, 2); EZX (Mesh, Surgical, Metal, 1); JDN (Implant, Fixation Device, Spinal, 1).
Next steps
- See all 5 Stuart clearances with predicates and recalls
- Run predicate analysis for product code KWQ, Stuart's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.