Paceart, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Paceart, Inc.” (first 1987, latest 2001), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 119 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 |
|---|---|---|---|
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 6 | 6 |
| KRE | Analyzer, Pacemaker Generator Function, Indirect | 2 | 2 |
| DRX | Electrode, Electrocardiograph | 1 | 1 |
Review panels
- Cardiovascular (9)
Most recent Paceart, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K012407 | PACEART TX3 CARDIAC EVENT RECORDER | DXH | 2001-08-14 | 15 |
| K982090 | PACEART HOME TRAK PLUS EASI EVENT RECORDER SYSTEM | DXH | 1999-01-26 | 225 |
| K973141 | HEART ACCESS PLUS CARDIAC EVENT RECORDER | DXH | 1997-11-12 | 83 |
| K960721 | PACEART WRIST ELECTRODES | DRX | 1996-07-18 | 147 |
| K952065 | PACEART CARDIOVOICE | DXH | 1996-01-16 | 259 |
| K931296 | PACEART CARDIOPHONE | DXH | 1993-10-01 | 185 |
| K915632 | PACEART CPTS-86/12 | KRE | 1992-04-14 | 119 |
| K880283 | PACEART PACEMAKER PATIENT TEST SYST/TEL OPT CPTS | DXH | 1988-03-09 | 47 |
| K870909 | PACEMAKER FUNCTION ANALYZER | KRE | 1987-04-27 | 53 |
Recalls
openFDA lists no recalls under a recalling firm named Paceart, 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 Paceart, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Paceart, Inc.” (first 1987, latest 2001), across 3 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 Paceart, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Paceart, Inc. is 119 days.
Which FDA product codes appear under Paceart, Inc.?
The most frequent FDA product codes under this applicant name are DXH (Transmitters And Receivers, Electrocardiograph, Telephone, 6); KRE (Analyzer, Pacemaker Generator Function, Indirect, 2); DRX (Electrode, Electrocardiograph, 1).
Next steps
- See all 9 Paceart, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DXH, Paceart, 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.