Acra Cut, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Acra Cut, Inc.” (first 1983, latest 2003), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 76 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 |
|---|---|---|---|
| HBF | Drills, Burrs, Trephines & Accessories (Compound, Powered) | 3 | 3 |
| HAO | Instrument, Surgical, Non-Powered | 2 | 2 |
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) | 2 | 2 |
| HBO | Clip, Scalp | 1 | 1 |
Review panels
- Neurology (8)
Most recent Acra Cut, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K032970 | ACRA-CUT XPRESS 120 | HBF | 2003-12-08 | 76 |
| K944311 | ACRA-CUT | HBO | 1994-11-18 | 77 |
| K911819 | ACRA-CUT NEUROLOGICAL SURGICAL DEVICE-POWERED | HBE | 1991-09-10 | 139 |
| K911812 | ACRA-CUT WIRE PASS DRILL | HBE | 1991-09-10 | 139 |
| K910226 | DURAL DISSECTORS | HAO | 1991-02-12 | 25 |
| K910225 | BONE PAD REMOVER | HAO | 1991-02-12 | 25 |
| K892866 | AUTOMATIC CRANIAL DRILL (PERFORATOR) | HBF | 1989-06-15 | 57 |
| K833266 | ACRA-CUT | HBF | 1983-12-29 | 99 |
Recalls
openFDA lists no recalls under a recalling firm named Acra Cut, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Acra Cut, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Acra Cut, Inc.” (first 1983, latest 2003), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Acra Cut, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Acra Cut, Inc. is 76 days.
Which FDA product codes appear under Acra Cut, Inc.?
The most frequent FDA product codes under this applicant name are HBF (Drills, Burrs, Trephines & Accessories (Compound, Powered), 3); HAO (Instrument, Surgical, Non-Powered, 2); HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered), 2).
Next steps
- See all 8 Acra Cut, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HBF, Acra Cut, 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.