Farrall Instruments, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Farrall Instruments, Inc.” (first 1976, latest 1995), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 46 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 |
|---|---|---|---|
| LIL | Monitor, Penile Tumescence | 2 | 2 |
| HCB | Device, Aversive Conditioning | 1 | 1 |
| HCC | Device, Biofeedback | 1 | 1 |
| HIR | Perineometer | 1 | 1 |
| LEL | Device, Sleep Assessment | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Farrall Instruments, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K940128 | CAT-400UL PENILE PLETHYSMOGRAPH | LIL | 1995-01-10 | 365 |
| K936115 | CAT-600 PENILE PLETHYSMOGRAPH | LIL | 1995-01-10 | 690 |
| K821723 | BI-4520 DUAL IMPEDOMETER | — | 1982-09-15 | 98 |
| K821664 | PP-100, PERSONAL PERINEOMETER | HIR | 1982-07-13 | 46 |
| K792305 | A SLEEP ASSESSMENT DEVICE | LEL | 1979-12-20 | 34 |
| K781634 | VISUALAX | HCC | 1978-10-03 | 11 |
| K760166 | STIMULATOR, SONIC CONTROL (AS-1) | HCB | 1976-07-20 | 14 |
Recalls
openFDA lists no recalls under a recalling firm named Farrall Instruments, 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 Farrall Instruments, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Farrall Instruments, Inc.” (first 1976, latest 1995), across 6 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 Farrall Instruments, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Farrall Instruments, Inc. is 46 days.
Which FDA product codes appear under Farrall Instruments, Inc.?
The most frequent FDA product codes under this applicant name are LIL (Monitor, Penile Tumescence, 2); HCB (Device, Aversive Conditioning, 1); HCC (Device, Biofeedback, 1).
Next steps
- See all 7 Farrall Instruments, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LIL, Farrall Instruments, 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.