Perkins Mfg. Co.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Perkins Mfg. Co.” (first 1977, latest 1997), across 9 product codes in 2 review panels. Median 510(k) review time under this name: 61 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 |
|---|---|---|---|
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 4 | 4 |
| IZI | System, X-Ray, Angiographic | 3 | 3 |
| IYE | Accelerator, Linear, Medical | 1 | 1 |
| IZJ | Camera, X-Ray, Fluorographic, Cine Or Spot | 1 | 1 |
| KDT | Container, Specimen Mailer And Storage, Sterile | 1 | 1 |
| KQA | Device, Beam Limiting, X-Ray, Therapeutic | 1 | 1 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
| LMB | Device, Digital Image Storage, Radiological | 1 | 1 |
| OXO | Image-Intensified Fluoroscopic X-Ray System, Mobile | 1 | 1 |
Review panels
Most recent Perkins Mfg. Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K972136 | TV MONITOR (P12/17) | IZI | 1997-06-26 | 20 |
| K954222 | VIDEO ENHANCEMENT UNIT | LLZ | 1995-12-08 | 88 |
| K926348 | SC1000 SCAN CONVERTER | LMB | 1993-11-19 | 337 |
| K920550 | DISPLAY PROCESSOR - MODEL IDP5100 | JAA | 1992-04-13 | 67 |
| K915232 | GRUNDIG ELECTRONICS VARIOUS MODELS | IZI | 1992-01-09 | 48 |
| K910384 | VIDEO ANNOTATOR MODEL PK2310 | JAA | 1991-04-16 | 77 |
| K904986 | PROGRAMMABLE VIDEO CONTROLLER MODEL PK2060 | JAA | 1990-12-04 | 32 |
| K904540 | VIDEO SYSTEM INTERFACE MODELS | IZI | 1990-10-26 | 22 |
| K896615 | CINE CAMERA CONTROL MODEL PK2037 | IZJ | 1990-01-04 | 44 |
| K895500 | PATIENT POSITIONING ACCESSORIES | IYE | 1989-11-06 | 55 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Perkins Mfg. Co..
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.
- Perkins Electronics Co. (1 510(k)s)
- Perkins Healthcare Technologies (1 510(k)s)
- Perkins & Perkins, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Perkins Mfg. Co.?
FDA lists 14 510(k) clearances under the applicant name “Perkins Mfg. Co.” (first 1977, latest 1997), across 9 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 Perkins Mfg. Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Perkins Mfg. Co. is 61 days.
Which FDA product codes appear under Perkins Mfg. Co.?
The most frequent FDA product codes under this applicant name are JAA (System, X-Ray, Fluoroscopic, Image-Intensified, 4); IZI (System, X-Ray, Angiographic, 3); IYE (Accelerator, Linear, Medical, 1).
Next steps
- See all 14 Perkins Mfg. Co. clearances with predicates and recalls
- Run predicate analysis for product code JAA, Perkins Mfg. Co.'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.