Pace Tech, Inc.: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “Pace Tech, Inc.” (first 1988, latest 1996), across 7 product codes in 2 review panels. Median 510(k) review time under this name: 172 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 |
|---|---|---|---|
| DQA | Oximeter | 5 | 5 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 4 | 4 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 3 | 3 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 2 | 2 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | 2 |
| CBS | Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | 1 | 1 |
| DSK | Computer, Blood-Pressure | 1 | 1 |
Review panels
- Anesthesiology (9)
- Cardiovascular (9)
Most recent Pace Tech, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K951226 | VITALMAX 4000/MINIPACK 3100/3000 | DSK | 1996-11-21 | 612 |
| K953795 | VITALMAX 4100 | CBS | 1996-07-01 | 322 |
| K944541 | HANDYPACK 911SC | CCK | 1995-02-22 | 160 |
| K945385 | VITALMAX 800 PLUS/VITALMAX 810 PLUS/MINIPACK 300 | MHX | 1995-01-31 | 89 |
| K925701 | MINIPACK 911-STC | CCK | 1994-08-11 | 637 |
| K934385 | MINIPACK 3100/3000 MODIFICATION | DXN | 1994-08-10 | 335 |
| K933624 | VITALMAX 4000 | MHX | 1994-07-19 | 365 |
| K930559 | VITALMAX 800-C | CCK | 1993-09-03 | 212 |
| K912835 | MINI-PACK 911 SERIES | MHX | 1992-02-03 | 222 |
| K912880 | VITALMAX 510/520 | DQA | 1991-11-14 | 136 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Pace Tech, 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.
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 Medical (19 510(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 Tech, Inc.?
FDA lists 18 510(k) clearances under the applicant name “Pace Tech, Inc.” (first 1988, latest 1996), across 7 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 Pace Tech, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pace Tech, Inc. is 172 days.
Which FDA product codes appear under Pace Tech, Inc.?
The most frequent FDA product codes under this applicant name are DQA (Oximeter, 5); MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), 4); CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, 3).
Next steps
- See all 18 Pace Tech, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQA, Pace Tech, 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.