Sherwood Medical Co.: FDA clearances and approvals
Sherwood Medical Co. has 191 FDA 510(k) clearances (first 1976, latest 1998), across 84 product codes in 12 review panels. Median 510(k) review time: 43 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 |
|---|---|---|---|
| FMF | Syringe, Piston | 20 | 20 |
| FMI | Needle, Hypodermic, Single Lumen | 13 | 13 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 10 | 10 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 10 | 10 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 9 | 9 |
| BSY | Catheters, Suction, Tracheobronchial | 7 | 7 |
| FOS | Catheter, Umbilical Artery | 6 | 6 |
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | 4 | 4 |
| BTR | Tube, Tracheal (W/Wo Connector) | 4 | 4 |
| CAC | Apparatus, Autotransfusion | 4 | 4 |
Plus 74 more product codes.
Review panels
- General Hospital (60)
- Anesthesiology (34)
- Gastroenterology and Urology (23)
- Clinical Chemistry (19)
- General and Plastic Surgery (16)
- Cardiovascular (15)
- Hematology (11)
- Dental (4)
- Immunology (4)
- Ear, Nose and Throat (2)
- Obstetrics and Gynecology (1)
- Pathology (1)
Most recent Sherwood Medical Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K981365 | MAHURKAR 13.5 FR CUFFED CATHETER WITH CURVED EXTENSIONS | MSD | 1998-11-25 | 224 |
| K960982 | MONOJECT BLUNT I.V. ACCESS CANNULA/MONOJECT HYPODERMIC SYRINGE WITH BLUNT I.V. ACCESS CANNULA | FMI | 1996-12-23 | 287 |
| K962880 | SENSI-TOUCH COMBO SPINAL/EPIDURAL REGIONAL ANESTHESIA DELIVERY SYSTEM | CAZ | 1996-12-09 | 138 |
| K960574 | ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC CATHETER SYSTEM | FHO | 1996-08-05 | 175 |
| K960677 | KANGAROO JEJUNAL FEEDING SYSTEM | KNT | 1996-05-13 | 87 |
| K960632 | KANGAROO FEEDING TUBE PLACMENT STYLET | KNT | 1996-05-09 | 85 |
| K955831 | ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM | BSY | 1996-03-28 | 93 |
| K954429 | KANGAROO ENTRISTAR SKIN-LEVEL GASTROSTOMY KIT | KNT | 1996-03-08 | 168 |
| K954525 | SENSI-TOUCH EPIDURAL ANESTHESIA FILTER | BXN | 1996-01-19 | 112 |
| K950201 | ARGYLE(R) HYDROPHILIC COATED THORACIC CATHETER | JOL | 1995-12-15 | 331 |
181 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Sherwood Medical Co..
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 Co.'s product codes (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
- G0379 — Direct admission of patient for hospital observation care (via CAF)
Frequently asked questions
How many FDA 510(k) clearances does Sherwood Medical Co. have?
Sherwood Medical Co. has 191 FDA 510(k) clearances (first 1976, latest 1998), across 84 product codes in 12 review panels.
How long does FDA take to clear Sherwood Medical Co.'s 510(k)s?
The median time from FDA receipt to decision across Sherwood Medical Co.'s cleared 510(k)s is 43 days.
What devices does Sherwood Medical Co. make?
Its most frequent FDA product codes are FMF (Syringe, Piston, 20); FMI (Needle, Hypodermic, Single Lumen, 13); DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, 10).
Has Sherwood Medical Co. had device recalls?
openFDA lists no recalls under a recalling firm name matching Sherwood Medical Co. Related entities may recall under other names.
Next steps
- See all 191 Sherwood Medical Co. clearances with predicates and recalls
- Run predicate analysis for product code FMF, Sherwood Medical Co.'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.