Spenco Medical Corp.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Spenco Medical Corp.” (first 1979, latest 1998), across 10 product codes in 3 review panels. Median 510(k) review time under this name: 56 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 |
|---|---|---|---|
| FMP | Protector, Skin Pressure | 1 | 1 |
| FRO | Dressing, Wound, Drug | 1 | 1 |
| ILO | Pack, Hot Or Cold, Water Circulating | 1 | 1 |
| IMD | Pack, Hot Or Cold, Disposable | 1 | 1 |
| KCZ | Prosthesis, Breast, External, Used With Adhesive | 1 | 1 |
| KGX | Tape And Bandage, Adhesive | 1 | 1 |
| KMF | Bandage, Liquid | 1 | 1 |
| MDA | Elastomer, Silicone, For Scar Management | 1 | 1 |
| MGQ | Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | 1 | 1 |
| NAB | Gauze / Sponge,Nonresorbable For External Use | 1 | 1 |
Review panels
Most recent Spenco Medical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K981902 | SPENCO SILICONE GEL SHEET | MDA | 1998-06-25 | 24 |
| K922228 | 2ND SKIN STERILE ADHESIVE STRIP | KGX | 1992-12-11 | 213 |
| K911550 | 2ND SKIN MOIST BURN PADS WITH ALOE | MGQ | 1991-09-06 | 151 |
| K910927 | SPENCIO SKIN GUARD KIT | KMF | 1991-06-03 | 90 |
| K896533 | SPENCO BREAST FORMS | KCZ | 1989-12-13 | 29 |
| K894898 | 2ND SKIN NON-STICK MOIST BURN PADS | FRO | 1989-08-23 | 22 |
| K820906 | SPENCO CRYOPRESS | IMD | 1982-05-13 | 42 |
| K811184 | SPENCO DERMAL PADS | FMP | 1981-05-20 | 21 |
| K791726 | HYDROGEL-PREP | NAB | 1979-11-20 | 77 |
| K791162 | GELSKIN | ILO | 1979-09-04 | 71 |
Recalls
openFDA lists no recalls under a recalling firm named Spenco Medical Corp..
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 Spenco Medical Corp.?
FDA lists 10 510(k) clearances under the applicant name “Spenco Medical Corp.” (first 1979, latest 1998), across 10 product codes in 3 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 Spenco Medical Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Spenco Medical Corp. is 56 days.
Which FDA product codes appear under Spenco Medical Corp.?
The most frequent FDA product codes under this applicant name are FMP (Protector, Skin Pressure, 1); FRO (Dressing, Wound, Drug, 1); ILO (Pack, Hot Or Cold, Water Circulating, 1).
Next steps
- See all 10 Spenco Medical Corp. clearances with predicates and recalls
- Run predicate analysis for product code FMP, Spenco Medical Corp.'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.