American Sterilizer Co.: FDA clearances and approvals
American Sterilizer Co. has 36 FDA 510(k) clearances (first 1977, latest 1994), across 25 product codes in 8 review panels. Median 510(k) review time: 29 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 |
|---|---|---|---|
| JOJ | Indicator, Physical/Chemical Sterilization Process | 4 | 4 |
| FRG | Wrap, Sterilization | 3 | 3 |
| HSZ | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment | 3 | 3 |
| FQO | Table, Operating-Room, Ac-Powered | 2 | 2 |
| FRC | Indicator, Biological Sterilization Process | 2 | 2 |
| FSY | Light, Surgical, Ceiling Mounted | 2 | 2 |
| KQS | Table, Cystometric, Non-Electric And Accessories | 2 | 2 |
| BWN | Table And Attachments, Operating-Room | 1 | 1 |
| DWX | Stripper, Artery, Intraluminal | 1 | 1 |
| ECG | Sterilizer, Boiling Water | 1 | 1 |
Plus 15 more product codes.
Review panels
- General Hospital (13)
- General and Plastic Surgery (13)
- Orthopedic (3)
- Gastroenterology and Urology (2)
- Cardiovascular (1)
- Dental (1)
- Ear, Nose and Throat (1)
- Microbiology (1)
Most recent American Sterilizer Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K943288 | AMSCO SQ240 SURGICAL LIGHT | FSY | 1994-10-17 | 101 |
| K931872 | THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZER | FLF | 1994-02-07 | 299 |
| K922485 | CHEMDI-VHP CHEMICAL INDICATOR | JOJ | 1993-09-29 | 499 |
| K930493 | QUANTUM 3080 SURGICAL TABLE | FQO | 1993-06-22 | 141 |
| K905816 | ORTHOVISION TABLE | JEB | 1991-03-06 | 68 |
| K896674 | AMSCO QUANTUM LIGHT | FSY | 1990-01-03 | 37 |
| K895164 | EAGLE DS | ECG | 1989-11-17 | 87 |
| K882660 | GENERAL SURGICAL TABLE AND ACCESSORIES | FQO | 1988-07-25 | 27 |
| K880198 | GEMINI SURGICAL LIGHT | FSS | 1988-02-10 | 26 |
| K864846 | RADIOGRAPHIC - LEG SECTION | KQS | 1986-12-24 | 14 |
26 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named American Sterilizer 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.
Frequently asked questions
How many FDA 510(k) clearances does American Sterilizer Co. have?
American Sterilizer Co. has 36 FDA 510(k) clearances (first 1977, latest 1994), across 25 product codes in 8 review panels.
How long does FDA take to clear American Sterilizer Co.'s 510(k)s?
The median time from FDA receipt to decision across American Sterilizer Co.'s cleared 510(k)s is 29 days.
What devices does American Sterilizer Co. make?
Its most frequent FDA product codes are JOJ (Indicator, Physical/Chemical Sterilization Process, 4); FRG (Wrap, Sterilization, 3); HSZ (Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment, 3).
Has American Sterilizer Co. had device recalls?
openFDA lists no recalls under a recalling firm name matching American Sterilizer Co. Related entities may recall under other names.
Next steps
- See all 36 American Sterilizer Co. clearances with predicates and recalls
- Run predicate analysis for product code JOJ, American Sterilizer 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.