Howard Instruments, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Howard Instruments, Inc.” (first 1997, latest 2007), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 83 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 |
|---|---|---|---|
| HNO | Keratome, Ac-Powered | 3 | 3 |
| GEX | Powered Laser Surgical Instrument | 1 | 1 |
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | 1 | 1 |
Review panels
Most recent Howard Instruments, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K063104 | FOX MEDICAL DIODE LASER SYSTEM 810NM | GEX | 2007-05-16 | 279 |
| K030948 | VMATE MODEL VMM1000 | HQE | 2003-06-17 | 83 |
| K980985 | SCMD-1000 | HNO | 1998-05-01 | 45 |
| K974598 | MICROKERATOME OR THE MATE | HNO | 1998-04-22 | 134 |
| K972727 | CBALK-1000 BLADE | HNO | 1997-10-10 | 81 |
Recalls
openFDA lists no recalls under a recalling firm named Howard Instruments, 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.
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.
- Howard Associates, Inc. (3 510(k)s)
- Howard Medical Co. (3 510(k)s)
- Howard, Hills & Harsh (2 510(k)s)
- Howard J. Nethery & Assoc. (1 510(k)s)
- Howard K. Mann & Assoc. (1 510(k)s)
- Howard N. Amos Design & Mfg. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Howard Instruments, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Howard Instruments, Inc.” (first 1997, latest 2007), across 3 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 Howard Instruments, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Howard Instruments, Inc. is 83 days.
Which FDA product codes appear under Howard Instruments, Inc.?
The most frequent FDA product codes under this applicant name are HNO (Keratome, Ac-Powered, 3); GEX (Powered Laser Surgical Instrument, 1); HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered, 1).
Next steps
- See all 5 Howard Instruments, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HNO, Howard Instruments, 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.