Amsco Sterile Recoveries, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Amsco Sterile Recoveries, Inc.” (first 1992, latest 1994), across 7 product codes in 3 review panels. Median 510(k) review time under this name: 422 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under STERIS, based on public ownership records.
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 |
|---|---|---|---|
| KKX | Drape, Surgical, Antimicrobial | 3 | 3 |
| FRG | Wrap, Sterilization | 2 | 2 |
| FYA | Gown, Surgical | 2 | 2 |
| FYC | Gown, Isolation, Surgical | 2 | 2 |
| FXP | Cover, Shoe, Operating-Room | 1 | 1 |
| KNC | Table, Obstetric (And Accessories) | 1 | 1 |
| LRD | Applicator, Ent Drug | 1 | 1 |
Review panels
Most recent Amsco Sterile Recoveries, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K932522 | AMSCO STERILE RECOVERIES SURGICAL PACKS | LRD | 1994-09-09 | 472 |
| K931143 | AMSCO STERILE RECOVERIES ABSORBENT TOWELS | KKX | 1994-09-08 | 552 |
| K931146 | SURGICAL DRAPES, MODIFICATION | KKX | 1994-06-13 | 465 |
| K931875 | AUTOCLAVABLE REUSABLE WRAP -- CENTERAL SERVICE USE | FRG | 1994-06-10 | 422 |
| K931874 | RECOVERIES AUTOCLAVABLE RESUABLE WRAP -- FAC. USE | FRG | 1994-06-10 | 422 |
| K931145 | NON-STERILE ISOLATION GOWN | FYC | 1994-06-10 | 462 |
| K931144 | STERILE SURGEON'S GOWN, MODIFICATION | FYA | 1994-06-10 | 462 |
| K932035 | NON-LINTING DELIVERY BLANKET | KNC | 1994-05-26 | 394 |
| K925815 | REUSABLE LIQUIDPROOF BOOTIE | FXP | 1993-07-09 | 234 |
| K921049 | SURGICAL DRAPE | KKX | 1992-10-01 | 210 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Amsco Sterile Recoveries, Inc..
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.
- Amsco Co. (19 510(k)s)
- Amsco American Sterilizer Co. (1 510(k)s)
- Amsco Hospital Products Co. (1 510(k)s)
- Amsco Intl., Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Amsco Sterile Recoveries, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Amsco Sterile Recoveries, Inc.” (first 1992, latest 1994), across 7 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 Amsco Sterile Recoveries, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Amsco Sterile Recoveries, Inc. is 422 days.
Which FDA product codes appear under Amsco Sterile Recoveries, Inc.?
The most frequent FDA product codes under this applicant name are KKX (Drape, Surgical, Antimicrobial, 3); FRG (Wrap, Sterilization, 2); FYA (Gown, Surgical, 2).
Next steps
- See all 12 Amsco Sterile Recoveries, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KKX, Amsco Sterile Recoveries, Inc.'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.