Hoffrel Instruments, Inc.: FDA clearances and approvals
Hoffrel Instruments, Inc. has 12 FDA 510(k) clearances (first 1978, latest 1987), across 5 product codes in 3 review panels. Median 510(k) review time: 94 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 |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 4 | 4 |
| ITX | Transducer, Ultrasonic, Diagnostic | 2 | 2 |
| JOP | Transducer, Ultrasonic | 2 | 2 |
| DKX | Thin Layer Chromatography, Barbiturate | 1 | 1 |
Plus 1 more product codes.
Review panels
- Radiology (6)
- Cardiovascular (2)
- Clinical Toxicology (1)
Most recent Hoffrel Instruments, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K870850 | MOD 482 | JOP | 1987-09-08 | 189 |
| K860235 | MOD 426, MEDICAL ULTRASONIC DIAGNOSTC TRANSDUCER | ITX | 1986-05-15 | 113 |
| K850165 | MOTOR DRIVE, MECHANICAL SECTOR SCANNING-MOD417 | JOP | 1985-10-23 | 280 |
| K844916 | MODEL 518 & 519 ULTRASONOSCOPE W/DOPPLER | IYO | 1985-04-22 | 125 |
| K834277 | MOD 427 | IYO | 1984-02-17 | 109 |
| K834276 | MOD 456 | IYO | 1984-02-17 | 109 |
| K837282 | MODEL VPS VASCULAR PROFILE SYSTEM | — | 1983-04-26 | 42 |
| K837229 | TRANSDUCER MODELS 450, 451, 452, 453, 454 | — | 1983-04-15 | 45 |
| K837142 | TRANSDUCERS MODELS 421, 419 AND 420 FOR IREX SYSTEM | — | 1983-03-23 | 79 |
| K800364 | ULTRASONIC DIAGNOSTIC SYSTEM, MOD. 202 | DKX | 1980-03-12 | 21 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Hoffrel Instruments, Inc..
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 Hoffrel Instruments, Inc. have?
Hoffrel Instruments, Inc. has 12 FDA 510(k) clearances (first 1978, latest 1987), across 5 product codes in 3 review panels.
How long does FDA take to clear Hoffrel Instruments, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Hoffrel Instruments, Inc.'s cleared 510(k)s is 94 days.
What devices does Hoffrel Instruments, Inc. make?
Its most frequent FDA product codes are IYO (System, Imaging, Pulsed Echo, Ultrasonic, 4); ITX (Transducer, Ultrasonic, Diagnostic, 2); JOP (Transducer, Ultrasonic, 2).
Has Hoffrel Instruments, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Hoffrel Instruments, Inc. Related entities may recall under other names.
Next steps
- See all 12 Hoffrel Instruments, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IYO, Hoffrel Instruments, Inc.'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.