The Huxley Instrument Corp.: FDA filings under this applicant name
FDA lists 53 510(k) clearances under the applicant name “The Huxley Instrument Corp.” (first 1985, latest 1985), across 14 product codes in 7 review panels. Median 510(k) review time under this name: 19 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 |
|---|---|---|---|
| HTD | Forceps | 9 | 9 |
| GEN | Forceps, General & Plastic Surgery | 8 | 8 |
| KOA | Surgical Instruments, G-U, Manual (And Accessories) | 5 | 5 |
| HTY | Pin, Fixation, Smooth | 4 | 4 |
| GAD | Retractor | 3 | 3 |
| GDZ | Handle, Scalpel | 2 | 2 |
| EMG | Forceps, Tooth Extractor, Surgical | 1 | 1 |
| FYH | Splint, Extremity, Noninflatable, External, Sterile | 1 | 1 |
| GDJ | Clamp, Surgical, General & Plastic Surgery | 1 | 1 |
| GWZ | Percussor | 1 | 1 |
Plus 4 more product codes.
Review panels
- General and Plastic Surgery (23)
- Gastroenterology and Urology (5)
- Orthopedic (4)
- Obstetrics and Gynecology (3)
- Dental (1)
- General Hospital (1)
- Neurology (1)
Most recent The Huxley Instrument Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K852721 | BOZEMAN UTERINE FORCEPS, STRAIGHT, 10+410 0R 420 | HCZ | 1985-09-06 | 72 |
| K853016 | STILLE ANGULAR RONGEUR, 8-3/4 SS 410 | — | 1985-08-07 | 21 |
| K852993 | BONE RONGEURS | — | 1985-08-07 | 23 |
| K853015 | SELF-CENTERING BONE HOLDING FORCEPS, 10-1/4 SS420 | GEN | 1985-07-29 | 12 |
| K852716 | TAYLOR PERCUSSION HAMMER SS 410 OR 420 | GWZ | 1985-07-26 | 30 |
| K852735 | SCALPEL HANDLE #7 SS 410 OR 420 | GDZ | 1985-07-15 | 19 |
| K852734 | O.R. SCISSORS, STRAIGHT, 5-1/2+SHP/SHP SS | — | 1985-07-15 | 19 |
| K852732 | IRIS SCISSORS, CURVED, 4-1/2+SS 410 OR 420 | — | 1985-07-15 | 19 |
| K852731 | LISTER BANDAGE SCISSORS, 5-1/2+SS 410 OR 420 | — | 1985-07-15 | 19 |
| K852730 | CRILE FORCEPS, STRIAGHT, 6-1/4+SS 410 OR 420 | GEN | 1985-07-15 | 19 |
43 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named The Huxley Instrument Corp..
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.
- Huxley Medical (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under The Huxley Instrument Corp.?
FDA lists 53 510(k) clearances under the applicant name “The Huxley Instrument Corp.” (first 1985, latest 1985), across 14 product codes in 7 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 The Huxley Instrument Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name The Huxley Instrument Corp. is 19 days.
Which FDA product codes appear under The Huxley Instrument Corp.?
The most frequent FDA product codes under this applicant name are HTD (Forceps, 9); GEN (Forceps, General & Plastic Surgery, 8); KOA (Surgical Instruments, G-U, Manual (And Accessories), 5).
Next steps
- See all 53 The Huxley Instrument Corp. clearances with predicates and recalls
- Run predicate analysis for product code HTD, The Huxley Instrument Corp.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.