Accutome, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Accutome, Inc.” (first 1981, latest 2015), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 84 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 | 1 | 90 |
| 2014 | 1 | 252 |
| 2015 | 1 | 77 |
| 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 |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 5 | 5 |
| HKY | Tonometer, Manual | 1 | 1 |
| HOE | Caliper, Ophthalmic | 1 | 1 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 1 | 1 |
Review panels
- Radiology (6)
- Ophthalmic (2)
Most recent Accutome, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K152573 | 4Sight | IYO | 2015-11-25 | 77 |
| K132549 | ACCUTIP COVER | HKY | 2014-04-23 | 252 |
| K123349 | A-SCAN PLUS CONNECT | IYO | 2013-01-29 | 90 |
| K103471 | UBM PLUS | IYN | 2011-03-14 | 110 |
| K050552 | PACHPEN PACHYMETER, MODEL 24-5100 | IYO | 2005-03-28 | 25 |
| K032956 | ACCUSONIC A-SCAN MODEL, 24-4000 | IYO | 2003-10-10 | 18 |
| K820050 | KREMER BLADE GAUGE | HOE | 1982-02-24 | 47 |
| K810660 | KREMER CORNEOMETER ULTRASONIC PACHOMETER | IYO | 1981-08-21 | 163 |
Recalls
openFDA lists no recalls under a recalling firm named Accutome, 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.
- Accutome Ultrasound, Inc. (3 510(k)s)
- Accutome, Inc. Doing Business AS Keeler USA (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Accutome, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Accutome, Inc.” (first 1981, latest 2015), across 4 product codes in 2 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 Accutome, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Accutome, Inc. is 84 days.
Which FDA product codes appear under Accutome, Inc.?
The most frequent FDA product codes under this applicant name are IYO (System, Imaging, Pulsed Echo, Ultrasonic, 5); HKY (Tonometer, Manual, 1); HOE (Caliper, Ophthalmic, 1).
Next steps
- See all 8 Accutome, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IYO, Accutome, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.