G.D. Searle and Co.: FDA filings under this applicant name
FDA lists 56 510(k) clearances under the applicant name “G.D. Searle and Co.” (first 1976, latest 1982), across 37 product codes in 11 review panels. Median 510(k) review time under this name: 24 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 |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 5 | 5 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 3 | 3 |
| JQW | Station, Pipetting And Diluting, For Clinical Use | 3 | 3 |
| KKX | Drape, Surgical, Antimicrobial | 3 | 3 |
| KOD | Catheter, Urological | 3 | 3 |
| CDX | Radioimmunoassay, Total Thyroxine | 2 | 2 |
| DBI | Complement C4, Antigen, Antiserum, Control | 2 | 2 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 2 | 2 |
| FYA | Gown, Surgical | 2 | 2 |
| JJJ | Counter (Beta, Gamma) For Clinical Use | 2 | 2 |
Plus 27 more product codes.
Review panels
- Clinical Chemistry (12)
- Gastroenterology and Urology (10)
- Radiology (10)
- General Hospital (7)
- Immunology (5)
- Obstetrics and Gynecology (3)
- Cardiovascular (2)
- General and Plastic Surgery (2)
- Clinical Toxicology (2)
- Anesthesiology (1)
- Microbiology (1)
Most recent G.D. Searle and Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K821159 | IN-LINE OXYGEN MONITORING SYSTEM | DRY | 1982-05-25 | 33 |
| K811068 | BYPASS COIL | KPY | 1981-05-27 | 40 |
| K811071 | VENOUS OXYGEN PROBE | CCE | 1981-05-05 | 15 |
| K803238 | INTRAVASCULAR CATHETER | FOZ | 1981-04-23 | 121 |
| K810630 | SILICONE ELASTOMER COATED LATEX FOLEY | KOD | 1981-03-31 | 22 |
| K810131 | ADMINISTRATION SET | FPD | 1981-02-26 | 38 |
| K802485 | SEARLE VASCULAR LOOPS | KDC | 1981-02-12 | 125 |
| K801805 | METRONIDAZOLE DISCS | JWY | 1981-02-10 | 196 |
| K810112 | SWR DISPOSABLE PREP RAZOR | KDC | 1981-02-04 | 19 |
| K802280 | WHITE KNIGHT DRAPE SEAL | KKX | 1980-10-10 | 22 |
46 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named G.D. Searle and Co..
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under G.D. Searle and Co. (a text match, not an official crosswalk):
- L8678 — Electrical stimulator supplies (external) for use with implantable neurostimulator, per month (via KPI)
- C1767 — Generator, neurostimulator (implantable), non-rechargeable (via KPI)
Frequently asked questions
How many FDA 510(k) clearances are listed under G.D. Searle and Co.?
FDA lists 56 510(k) clearances under the applicant name “G.D. Searle and Co.” (first 1976, latest 1982), across 37 product codes in 11 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 G.D. Searle and Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name G.D. Searle and Co. is 24 days.
Which FDA product codes appear under G.D. Searle and Co.?
The most frequent FDA product codes under this applicant name are IYO (System, Imaging, Pulsed Echo, Ultrasonic, 5); CDP (Radioimmunoassay, Total Triiodothyronine, 3); JQW (Station, Pipetting And Diluting, For Clinical Use, 3).
Next steps
- See all 56 G.D. Searle and Co. clearances with predicates and recalls
- Run predicate analysis for product code IYO, G.D. Searle and Co.'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.