Simpson/Basye, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Simpson/Basye, Inc.” (first 1978, latest 1994), across 10 product codes in 4 review panels. Median 510(k) review time under this name: 28 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 |
|---|---|---|---|
| HDC | Tenaculum, Uterine | 3 | 3 |
| FSM | Tray, Surgical, Instrument | 1 | 1 |
| GCO | Endoscope, Mirror | 1 | 1 |
| GEN | Forceps, General & Plastic Surgery | 1 | 1 |
| HGI | Electrocautery, Gynecologic (And Accessories) | 1 | 1 |
| KNA | Instrument, Manual, Specialized Obstetric-Gynecologic | 1 | 1 |
| KOA | Surgical Instruments, G-U, Manual (And Accessories) | 1 | 1 |
| KOH | Instrument, Manual, General Obstetric-Gynecologic | 1 | 1 |
| KXF | Applicator, Absorbent Tipped, Non-Sterile | 1 | 1 |
| LRJ | Disinfectant, Medical Devices | 1 | 1 |
Review panels
- Obstetrics and Gynecology (6)
- Gastroenterology and Urology (2)
- General Hospital (2)
- General and Plastic Surgery (2)
Most recent Simpson/Basye, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K926179 | SEDLACEK HANDLE | HGI | 1994-03-25 | 472 |
| K891352 | MARLOW ANAL SPECULUM | KOA | 1989-06-23 | 105 |
| K891351 | NEWPORT LATERAL VAGINAL RETRACTOR | KOH | 1989-05-11 | 62 |
| K891350 | NEWPORT CERVICAL MANIPULATOR | HDC | 1989-03-29 | 19 |
| K891349 | CAMPION CERVICAL HOOK | HDC | 1989-03-29 | 19 |
| K891347 | REID ENDOCERVICAL SPREADER | HDC | 1989-03-29 | 19 |
| K891348 | CAMPION LASER FORCEPS | GEN | 1989-03-22 | 12 |
| K870276 | HEATED INSTRUMENT BATH | LRJ | 1987-05-07 | 100 |
| K862717 | HAND MIRROR (ENDOSCOPE) | GCO | 1986-07-30 | 13 |
| K862629 | SURGICAL LASER ACCESSORIES (SLA) CASE | FSM | 1986-07-17 | 7 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Simpson/Basye, 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 Simpson/Basye, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Simpson/Basye, Inc.” (first 1978, latest 1994), across 10 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 Simpson/Basye, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Simpson/Basye, Inc. is 28 days.
Which FDA product codes appear under Simpson/Basye, Inc.?
The most frequent FDA product codes under this applicant name are HDC (Tenaculum, Uterine, 3); FSM (Tray, Surgical, Instrument, 1); GCO (Endoscope, Mirror, 1).
Next steps
- See all 12 Simpson/Basye, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HDC, Simpson/Basye, 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.