Chase Mfg. Co.: FDA clearances and approvals
Chase Mfg. Co. has 10 FDA 510(k) clearances (first 1977, latest 1979), across 9 product codes in 5 review panels. Median 510(k) review time: 54 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 |
|---|---|---|---|
| ITM | Cage, Knee | 2 | 2 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 1 | 1 |
| FCE | Enema Kit | 1 | 1 |
| FMW | Cover, Mattress (Medical Purposes) | 1 | 1 |
| FRG | Wrap, Sterilization | 1 | 1 |
| HSP | Splint, Traction | 1 | 1 |
| ILG | Stocking, Elastic | 1 | 1 |
| IMD | Pack, Hot Or Cold, Disposable | 1 | 1 |
| MMK | Container, Sharps | 1 | 1 |
Review panels
- Physical Medicine (4)
- General Hospital (3)
- Cardiovascular (1)
- Gastroenterology and Urology (1)
- Orthopedic (1)
Most recent Chase Mfg. Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K791513 | ADAMCO DUST COVER | FRG | 1979-10-11 | 76 |
| K790993 | INSTANT HOT & COLD PACKS | IMD | 1979-09-07 | 101 |
| K790644 | SUBMAX | DRT | 1979-04-26 | 27 |
| K780033 | MATTRESSES, CONDUCTIVE & COVERS | FMW | 1978-02-21 | 43 |
| K771792 | ENEMA SET | FCE | 1977-10-20 | 28 |
| K771791 | NEEDLE COUNTING | MMK | 1977-10-04 | 12 |
| K770900 | CAST BRWM, FRACTURE | ITM | 1977-07-21 | 66 |
| K770899 | FRACTURE CAST BRACE, POLY | ITM | 1977-07-21 | 66 |
| K770898 | FRACTURE CAST BRACE KIT, PLASTIC | HSP | 1977-07-21 | 66 |
| K770173 | STOCKINETTE | ILG | 1977-02-08 | 13 |
Recalls
openFDA lists no recalls under a recalling firm named Chase Mfg. 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 Chase Mfg. Co. have?
Chase Mfg. Co. has 10 FDA 510(k) clearances (first 1977, latest 1979), across 9 product codes in 5 review panels.
How long does FDA take to clear Chase Mfg. Co.'s 510(k)s?
The median time from FDA receipt to decision across Chase Mfg. Co.'s cleared 510(k)s is 54 days.
What devices does Chase Mfg. Co. make?
Its most frequent FDA product codes are ITM (Cage, Knee, 2); DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), 1); FCE (Enema Kit, 1).
Has Chase Mfg. Co. had device recalls?
openFDA lists no recalls under a recalling firm name matching Chase Mfg. Co. Related entities may recall under other names.
Next steps
- See all 10 Chase Mfg. Co. clearances with predicates and recalls
- Run predicate analysis for product code ITM, Chase Mfg. 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.