Sherwood Medical Industries: FDA clearances and approvals
Sherwood Medical Industries has 62 FDA 510(k) clearances (first 1976, latest 1980), across 46 product codes in 12 review panels. Median 510(k) review time: 22 days.
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 |
|---|---|---|---|
| GIM | Tubes, Vacuum Sample, With Anticoagulant | 5 | 5 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 3 | 3 |
| FYF | Cap, Surgical | 3 | 3 |
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 3 | 3 |
| BZQ | Monitor, Breathing Frequency | 2 | 2 |
| CCE | Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling | 2 | 2 |
| CCT | Applicator (Laryngo-Tracheal), Topical Anesthesia | 2 | 2 |
| DWS | Instruments, Surgical, Cardiovascular | 2 | 2 |
| FXY | Hood, Surgical | 2 | 2 |
| KDH | Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration | 2 | 2 |
Plus 36 more product codes.
Review panels
- Anesthesiology (14)
- Clinical Chemistry (13)
- General Hospital (12)
- General and Plastic Surgery (7)
- Gastroenterology and Urology (5)
- Cardiovascular (4)
- Pathology (2)
- Dental (1)
- Hematology (1)
- Immunology (1)
- Obstetrics and Gynecology (1)
- Ophthalmic (1)
Most recent Sherwood Medical Industries 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K801070 | SHERWOOD DISPOSABLE ENDOMETRIAL SAMPLES | HHK | 1980-07-21 | 76 |
| K801071 | LANCER GLUCOSE RATE REAGENT KIT | CGA | 1980-05-23 | 17 |
| K792014 | LANCER L-INA BUFFER, POLYMER, WASH SOLU | JZW | 1979-11-13 | 39 |
| K792013 | LANCER L-INA HUMAN REFERENCE SERUM | JIX | 1979-11-13 | 39 |
| K782077 | LANCER ICE CUBE | JRM | 1979-04-03 | 111 |
| K790523 | ARGYLE ESOPHAGEAL STETHOSCOPE | BZW | 1979-03-27 | 12 |
| K790196 | MONOJECT ARTERIAL BLOOD SAMPLING DEVICE | CBT | 1979-03-13 | 47 |
| K790197 | REAGENT KIT, LANCER GLUCOSE | JJF | 1979-03-12 | 46 |
| K781459 | MONOJECT SCALE MAGNIFIER | HJY | 1978-10-24 | 62 |
| K781060 | MONOJECT ENDOSSEOUS DENTAL IMPLANT | DZE | 1978-08-14 | 49 |
52 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Sherwood Medical Industries.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Sherwood Medical Industries's product codes (a text match, not an official crosswalk):
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via JCY)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via JCY)
Frequently asked questions
How many FDA 510(k) clearances does Sherwood Medical Industries have?
Sherwood Medical Industries has 62 FDA 510(k) clearances (first 1976, latest 1980), across 46 product codes in 12 review panels.
How long does FDA take to clear Sherwood Medical Industries's 510(k)s?
The median time from FDA receipt to decision across Sherwood Medical Industries's cleared 510(k)s is 22 days.
What devices does Sherwood Medical Industries make?
Its most frequent FDA product codes are GIM (Tubes, Vacuum Sample, With Anticoagulant, 5); FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, 3); FYF (Cap, Surgical, 3).
Has Sherwood Medical Industries had device recalls?
openFDA lists no recalls under a recalling firm name matching Sherwood Medical Industries. Related entities may recall under other names.
Next steps
- See all 62 Sherwood Medical Industries clearances with predicates and recalls
- Run predicate analysis for product code GIM, Sherwood Medical Industries's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.