O.R. Specialties, Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “O.R. Specialties, Inc.” (first 1981, latest 1994), across 9 product codes in 4 review panels. Median 510(k) review time under this name: 94 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 |
|---|---|---|---|
| HQC | Unit, Phacofragmentation | 4 | 4 |
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | 3 | 3 |
| EFQ | Gauze/Sponge, Internal | 1 | 1 |
| EQH | Source, Carrier, Fiberoptic Light | 1 | 1 |
| ETD | Tube, Tympanostomy | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| GZX | Instrument, Microsurgical | 1 | 1 |
| KYG | Device, Irrigation, Ocular Surgery | 1 | 1 |
| LXP | Plug, Scleral | 1 | 1 |
Review panels
Most recent O.R. Specialties, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K942607 | LAPAROSCOPIC SCISSORS (DISPOSABLE) | GEI | 1994-07-06 | 35 |
| K923630 | PHACO NEEDLES 1000-R & 1000-O NEEDLES | HQC | 1994-04-06 | 624 |
| K925671 | DISPOSABLE SCLERAL PLUGS | LXP | 1993-08-02 | 265 |
| K923887 | JACK'S VENT TUBES | ETD | 1993-02-19 | 199 |
| K923774 | DISPOSABLE ENDOILLUMINATOR | EQH | 1992-10-19 | 83 |
| K922355 | POLLY'S VITREOUS SCISSORS J-225-S | HQE | 1992-08-18 | 91 |
| K922180 | LEWICKY O.R.S. TUBING | KYG | 1992-07-02 | 55 |
| K914038 | POLLY'S CUTTER J-225 | HQE | 1991-12-09 | 90 |
| K911932 | J105 JAMES SURGICAL SYSTEM I/A PACK | GZX | 1991-08-26 | 118 |
| K890195 | JAMES SURGICAL SYSTEM J1000 | HQE | 1989-08-03 | 197 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named O.R. Specialties, 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 O.R. Specialties, Inc.?
FDA lists 14 510(k) clearances under the applicant name “O.R. Specialties, Inc.” (first 1981, latest 1994), across 9 product codes in 4 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 O.R. Specialties, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name O.R. Specialties, Inc. is 94 days.
Which FDA product codes appear under O.R. Specialties, Inc.?
The most frequent FDA product codes under this applicant name are HQC (Unit, Phacofragmentation, 4); HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered, 3); EFQ (Gauze/Sponge, Internal, 1).
Next steps
- See all 14 O.R. Specialties, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HQC, O.R. Specialties, 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.