Prucka Engineering, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Prucka Engineering, Inc.” (first 1989, latest 2000), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 128 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 |
|---|---|---|---|
| DPS | Electrocardiograph | 2 | 2 |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 2 | 2 |
| DQK | Computer, Diagnostic, Programmable | 1 | 1 |
| DRR | Amplifier And Signal Conditioner, Biopotential | 1 | 1 |
Review panels
- Cardiovascular (6)
Most recent Prucka Engineering, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K993414 | PRUCKA ENGINEERING INC. CARDIOLAB EP SYSTEM,VERSION 4.2 | DPS | 2000-04-07 | 178 |
| K960321 | CARDIOCATH CATHETERIZATION LAB SYSTEM | DPS | 1996-08-21 | 212 |
| K904747 | PEI PLAQUE ELECTRODE ARRAY | DRF | 1991-10-09 | 355 |
| K910307 | CARDIOLAB AMPLIFIER MODULE (CAM) | DRR | 1991-04-12 | 78 |
| K902716 | PE ELECTROPHYSIOLOGY LAB SYSTEM (PEEP) | DQK | 1990-09-04 | 76 |
| K895916 | PE INTERCARDIAC MAPPING SYSTEM (ICMS) | DRF | 1989-12-13 | 64 |
Recalls
openFDA lists no recalls under a recalling firm named Prucka Engineering, 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 Prucka Engineering, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Prucka Engineering, Inc.” (first 1989, latest 2000), 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 Prucka Engineering, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Prucka Engineering, Inc. is 128 days.
Which FDA product codes appear under Prucka Engineering, Inc.?
The most frequent FDA product codes under this applicant name are DPS (Electrocardiograph, 2); DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording, 2); DQK (Computer, Diagnostic, Programmable, 1).
Next steps
- See all 6 Prucka Engineering, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DPS, Prucka Engineering, 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.