Stephens Instruments: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Stephens Instruments” (first 2002, latest 2002), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 66 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 |
|---|---|---|---|
| HNC | Specula, Ophthalmic | 1 | 1 |
| HNF | Scissors, Ophthalmic | 1 | 1 |
| HNQ | Hook, Ophthalmic | 1 | 1 |
| HNR | Forceps, Ophthalmic | 1 | 1 |
| HRH | Trephine, Manual, Ophthalmic | 1 | 1 |
Review panels
- Ophthalmic (5)
Most recent Stephens Instruments 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K022843 | GAYHEART CORNEAL EXCISION DEVICE | HRH | 2002-11-01 | 66 |
| K022842 | STEPHENS DISPOSABLE HOOKS | HNQ | 2002-11-01 | 66 |
| K022840 | STEPHENS DISPOSABLE SCISSORS | HNF | 2002-11-01 | 66 |
| K022836 | STEPHENS DISPOSABLE SPECULUM | HNC | 2002-11-01 | 66 |
| K022835 | STEPHENS DISPOSABLE FORCEPS | HNR | 2002-11-01 | 66 |
Recalls
openFDA lists no recalls under a recalling firm named Stephens Instruments.
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.
- Stephens Scientific (4 510(k)s)
- Stephens Mfg. Co. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Stephens Instruments?
FDA lists 5 510(k) clearances under the applicant name “Stephens Instruments” (first 2002, latest 2002), across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Stephens Instruments?
The median time from FDA receipt to decision across 510(k)s cleared under the name Stephens Instruments is 66 days.
Which FDA product codes appear under Stephens Instruments?
The most frequent FDA product codes under this applicant name are HNC (Specula, Ophthalmic, 1); HNF (Scissors, Ophthalmic, 1); HNQ (Hook, Ophthalmic, 1).
Next steps
- See all 5 Stephens Instruments clearances with predicates and recalls
- Run predicate analysis for product code HNC, Stephens Instruments'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.