Cutter Laboratories, Inc.: FDA filings under this applicant name
FDA lists 39 510(k) clearances under the applicant name “Cutter Laboratories, Inc.” (first 1976, latest 1986), across 29 product codes in 9 review panels. Median 510(k) review time under this name: 25 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 |
|---|---|---|---|
| ELW | Material, Impression | 5 | 5 |
| CAH | Filter, Bacterial, Breathing-Circuit | 3 | 3 |
| EMA | Cement, Dental | 2 | 2 |
| ITG | Bandage, Cast | 2 | 2 |
| BWF | Spirometer, Therapeutic (Incentive) | 1 | 1 |
| CBF | Chamber, Hyperbaric | 1 | 1 |
| EBH | Material, Impression Tray, Resin | 1 | 1 |
| EFB | Handpiece, Air-Powered, Dental | 1 | 1 |
| EHL | Point, Abrasive | 1 | 1 |
| EJL | Bur, Dental | 1 | 1 |
Plus 19 more product codes.
Review panels
- Dental (11)
- General Hospital (8)
- Orthopedic (6)
- Physical Medicine (3)
- Anesthesiology (2)
- Gastroenterology and Urology (2)
- General and Plastic Surgery (2)
- Hematology (1)
- Radiology (1)
Most recent Cutter Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K861315 | HYPERBARIC PENETRATION EXTENSION SET | CBF | 1986-05-21 | 43 |
| K854106 | BAYSILEX | ELW | 1986-03-17 | 160 |
| K842324 | PERFOURM | ELW | 1984-11-09 | 149 |
| K834106 | INTRAVENOUS INFUSION CONTROLLER | LDR | 1984-05-30 | 183 |
| K832237 | ORTHOPEDIC CASTING TAPE MAXCAST | ITG | 1983-08-16 | 36 |
| K823214 | DOSIMETRIC RELEASE PROGRAM - ADMIN. SET | FPA | 1983-01-12 | 76 |
| K821326 | CUTTER BOND POLYCARBOXYLATE CEMENT | EMA | 1982-05-28 | 24 |
| K813532 | CUTTERBOND ZINC PHOSPHATE CEMENT | EMA | 1982-03-02 | 75 |
| K802105 | C-BLADE | HWE | 1980-09-16 | 13 |
| K802104 | C-SPLINT | IQI | 1980-09-16 | 13 |
29 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Cutter Laboratories, 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Cutter Laboratories, Inc. (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances are listed under Cutter Laboratories, Inc.?
FDA lists 39 510(k) clearances under the applicant name “Cutter Laboratories, Inc.” (first 1976, latest 1986), across 29 product codes in 9 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 Cutter Laboratories, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cutter Laboratories, Inc. is 25 days.
Which FDA product codes appear under Cutter Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are ELW (Material, Impression, 5); CAH (Filter, Bacterial, Breathing-Circuit, 3); EMA (Cement, Dental, 2).
Next steps
- See all 39 Cutter Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ELW, Cutter Laboratories, 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.