Stainless Mfg., Inc.: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Stainless Mfg., Inc.” (first 1980, latest 1984), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 36 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 |
|---|---|---|---|
| HTZ | Instrument, Cutting, Orthopedic | 9 | 9 |
| HXP | Instrument, Bending Or Contouring | 4 | 4 |
| HXB | Probe | 2 | 2 |
| LXH | Orthopedic Manual Surgical Instrument | 2 | 2 |
| HTF | Curette | 1 | 1 |
| HTP | File | 1 | 1 |
Review panels
Most recent Stainless Mfg., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K841980 | SIDE CUTTING SERRATED BLADE | HTZ | 1984-08-15 | 93 |
| K841982 | MENISCOTOME 4MM & 5MM | HTZ | 1984-06-19 | 36 |
| K841981 | 4MM & 5MM FILE | HTP | 1984-06-19 | 36 |
| K841979 | 4MM CUP CURRETTE | HTF | 1984-06-19 | 36 |
| K841978 | LATERAL RELEASE KNIFE 5MM & 7MM | HTZ | 1984-06-19 | 36 |
| K841977 | 5MM DOUGLE EDGE RING CURETTE | HTZ | 1984-06-19 | 36 |
| K841976 | HOOK KNIFE 4MM & 5MM | HTZ | 1984-06-19 | 36 |
| K841975 | ROSETTE KNIFE 4MM | HTZ | 1984-06-19 | 36 |
| K841974 | RETROGRADE KNIFE 4MM & 5MM | HTZ | 1984-06-19 | 36 |
| K841973 | BANANA KNIFE SERRATED | HTZ | 1984-06-19 | 36 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Stainless Mfg., Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Stainless Mfg., Inc.?
FDA lists 19 510(k) clearances under the applicant name “Stainless Mfg., Inc.” (first 1980, latest 1984), across 6 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 Stainless Mfg., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Stainless Mfg., Inc. is 36 days.
Which FDA product codes appear under Stainless Mfg., Inc.?
The most frequent FDA product codes under this applicant name are HTZ (Instrument, Cutting, Orthopedic, 9); HXP (Instrument, Bending Or Contouring, 4); HXB (Probe, 2).
Next steps
- See all 19 Stainless Mfg., Inc. clearances with predicates and recalls
- Run predicate analysis for product code HTZ, Stainless Mfg., Inc.'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.