Wilshire Medical Products: FDA clearances and approvals
Wilshire Medical Products has 12 FDA 510(k) clearances (first 1993, latest 1995), across 5 product codes in 2 review panels. Median 510(k) review time: 64 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 |
|---|---|---|---|
| FRO | Dressing, Wound, Drug | 6 | 6 |
| MGQ | Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | 3 | 3 |
| KMF | Bandage, Liquid | 1 | 1 |
| KMK | Device, Intravascular Catheter Securement | 1 | 1 |
| MGP | Dressing, Wound And Burn, Occlusive | 1 | 1 |
Review panels
Most recent Wilshire Medical Products 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K946031 | DERMASSIST(TM) HYDROGEL SATURATEED NON WOVEN DRESSING | MGQ | 1995-02-27 | 80 |
| K946030 | DERMASSIST(TM) HYDROGEL SATURATED GAUZE DRESSING | MGQ | 1995-02-27 | 80 |
| K944333 | HYDRODERM GEL WOUND DRESSING | MGQ | 1994-11-10 | 65 |
| K941216 | HYDRODERM EXTRA THIN INTELLIGENT HYDROCOLLIOID DRESSING | KMF | 1994-05-20 | 67 |
| K941149 | DERMAASSIST HYDROCOLLOID DRESSING | FRO | 1994-05-20 | 71 |
| K941005 | DERMASSIST(TM) XEROFORM PETROLATUM DRESSING | FRO | 1994-04-14 | 44 |
| K940076 | DERMASSIST WET DRESSING, WATER | FRO | 1994-03-03 | 56 |
| K940044 | DERMASSIST WET DRESSING, SALINE | FRO | 1994-03-03 | 57 |
| K936234 | DERMASSIST OIL EMULSION NON-ADHERING WOUND DRESSING | FRO | 1994-03-03 | 64 |
| K936230 | DERMASSIST PETROLATUM GAUZE,USP | FRO | 1994-03-03 | 64 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Wilshire Medical Products.
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.
Frequently asked questions
How many FDA 510(k) clearances does Wilshire Medical Products have?
Wilshire Medical Products has 12 FDA 510(k) clearances (first 1993, latest 1995), across 5 product codes in 2 review panels.
How long does FDA take to clear Wilshire Medical Products's 510(k)s?
The median time from FDA receipt to decision across Wilshire Medical Products's cleared 510(k)s is 64 days.
What devices does Wilshire Medical Products make?
Its most frequent FDA product codes are FRO (Dressing, Wound, Drug, 6); MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic, 3); KMF (Bandage, Liquid, 1).
Has Wilshire Medical Products had device recalls?
openFDA lists no recalls under a recalling firm name matching Wilshire Medical Products. Related entities may recall under other names.
Next steps
- See all 12 Wilshire Medical Products clearances with predicates and recalls
- Run predicate analysis for product code FRO, Wilshire Medical Products'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.