Scott Health Care: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Scott Health Care” (first 1990, latest 1995), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 97 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 |
|---|---|---|---|
| KMF | Bandage, Liquid | 4 | 4 |
| FRO | Dressing, Wound, Drug | 2 | 2 |
| HHD | Pad, Menstrual, Unscented | 1 | 1 |
| KGX | Tape And Bandage, Adhesive | 1 | 1 |
| NAB | Gauze / Sponge,Nonresorbable For External Use | 1 | 1 |
Review panels
Most recent Scott Health Care 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K954275 | MEPORE PLUS (9X15CM) | KMF | 1995-12-27 | 105 |
| K954274 | MEPORE (6X7) | KMF | 1995-12-19 | 97 |
| K945206 | ALLDRESS MULTI LAYERED WOUND DRESSING | KMF | 1995-01-12 | 79 |
| K932743 | MEFIX(R) ADHESIVE FABRIC FOR DRESSING FIXATION | KGX | 1993-09-10 | 94 |
| K905439 | HYPERGEL PROTECTIVE WOUND GEL | KMF | 1991-05-29 | 176 |
| K910857 | ALLDRESS MULTI LAYERED WOUND DRESSING | NAB | 1991-04-12 | 43 |
| K905438 | NORMLGEL PROTECTIVE WOUND GEL | FRO | 1991-04-01 | 118 |
| K900421 | PROMISE ABSORBENT PROTECTIVE PAD | HHD | 1990-06-06 | 127 |
| K897142 | MESALT STERILE DRESSING | FRO | 1990-03-27 | 90 |
Recalls
openFDA lists no recalls under a recalling firm named Scott Health Care.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Scott Laboratories, Inc. (16 510(k)s)
- Scott Imaging Intl., Inc. (7 510(k)s)
- Scott Paper Co. (3 510(k)s)
- Scott All-Sports, Inc. (2 510(k)s)
- Scott E Allen CP (1 510(k)s)
- Scott Feldman Dds & Norman Shapiro Dds (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Scott Health Care?
FDA lists 9 510(k) clearances under the applicant name “Scott Health Care” (first 1990, latest 1995), across 5 product codes in 2 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 Scott Health Care?
The median time from FDA receipt to decision across 510(k)s cleared under the name Scott Health Care is 97 days.
Which FDA product codes appear under Scott Health Care?
The most frequent FDA product codes under this applicant name are KMF (Bandage, Liquid, 4); FRO (Dressing, Wound, Drug, 2); HHD (Pad, Menstrual, Unscented, 1).
Next steps
- See all 9 Scott Health Care clearances with predicates and recalls
- Run predicate analysis for product code KMF, Scott Health Care'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.