Pace Medical: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Pace Medical” (first 1987, latest 2001), plus 1 PMA decision, across 9 product codes in 1 review panel. Median 510(k) review time under this name: 75 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 |
|---|---|---|---|
| DTE | Pulse-Generator, Pacemaker, External | 9 | 9 |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | 2 | 2 |
| DTB | Permanent Pacemaker Electrode | 2 | 2 |
| DXY | Implantable Pacemaker Pulse-Generator | 2 | 2 |
| DTC | Analyzer, Pacemaker Generator Function | 1 | 1 |
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | 1 | 1 |
| DYB | Introducer, Catheter | 1 | 1 |
| JOQ | Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only) | 1 | 0 |
| LDF | Electrode, Pacemaker, Temporary | 1 | 1 |
Review panels
- Cardiovascular (20)
Most recent Pace Medical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K011980 | ADAPTER, PACING ANALYZER/UNIVERSAL PACING ADAPTER, MODELS 4820 AND 4825 | DTE | 2001-09-12 | 79 |
| K012392 | DISPOSABLE SURGICAL EXTENSION CABLE, MODEL 4255 AND MODEL 4260 | DSA | 2001-09-04 | 39 |
| K002204 | PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265V | DTE | 2000-10-18 | 90 |
| K002497 | MODEL 4810 ANALYZER OUTPUT ADAPTER | DTC | 2000-10-10 | 57 |
| K002496 | MODEL 4815 ADAPTER | DTN | 2000-10-10 | 57 |
| K001180 | TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY PACEMAKER SURGICAL EXTENSION CABLE, MODELS 528 | DTE | 2000-06-27 | 77 |
| K925143 | MODEL 4800 ACCUPACE PACING SYSTEM ANALYER | DTE | 1994-09-27 | 714 |
| K931662 | LEAD INTRODUCER SET, VARIOUS MODELS AND SIZES | DYB | 1993-08-31 | 148 |
| K922899 | MODEL 4280 SURGICAL EXTENSION CABLE | DSA | 1992-12-23 | 190 |
| K913805 | MINIATURE MODELS 4562/4563/4572/4573 PACEMAKER | DTE | 1991-11-19 | 85 |
9 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P920032 | PMA | MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER | 1994-03-10 |
Recalls
openFDA lists no recalls under a recalling firm named Pace Medical.
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Pace Medical (a text match, not an official crosswalk):
- C1767 — Generator, neurostimulator (implantable), non-rechargeable (via DXY)
- C1820 — Generator, neurostimulator (implantable), with rechargeable battery and charging system (via DXY)
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.
- Pace Tech, Inc. (18 510(k)s)
- Pace Tech Medical Monitors, Inc. (3 510(k)s)
- Pace Pharmaceutical Services, Inc. (2 510(k)s)
- Pace Surgical (2 510(k)s)
- Pace West (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Pace Medical?
FDA lists 19 510(k) clearances under the applicant name “Pace Medical” (first 1987, latest 2001), plus 1 PMA decision, across 9 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 Pace Medical?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pace Medical is 75 days.
Which FDA product codes appear under Pace Medical?
The most frequent FDA product codes under this applicant name are DTE (Pulse-Generator, Pacemaker, External, 9); DSA (Cable, Transducer And Electrode, Patient, (Including Connector), 2); DTB (Permanent Pacemaker Electrode, 2).
Next steps
- See all 19 Pace Medical clearances with predicates and recalls
- Run predicate analysis for product code DTE, Pace Medical'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.