Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pace Tech, Inc. — Predicate Candidate Screening
18 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
174 daysmedian FDA review time
612 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K951226 | VITALMAX 4000/MINIPACK 3100/3000 | Pace Tech, Inc. | 1996-11-21 | 612 | 0 |
| K953795 | VITALMAX 4100 | Pace Tech, Inc. | 1996-07-01 | 322 | 0 |
| K944541 | HANDYPACK 911SC | Pace Tech, Inc. | 1995-02-22 | 160 | 0 |
| K945385 | VITALMAX 800 PLUS/VITALMAX 810 PLUS/MINIPACK 300 | Pace Tech, Inc. | 1995-01-31 | 89 | 0 |
| K925701 | MINIPACK 911-STC | Pace Tech, Inc. | 1994-08-11 | 637 | 0 |
| K934385 | MINIPACK 3100/3000 MODIFICATION | Pace Tech, Inc. | 1994-08-10 | 335 | 0 |
| K933624 | VITALMAX 4000 | Pace Tech, Inc. | 1994-07-19 | 365 | 0 |
| K930559 | VITALMAX 800-C | Pace Tech, Inc. | 1993-09-03 | 212 | 0 |
| K912835 | MINI-PACK 911 SERIES | Pace Tech, Inc. | 1992-02-03 | 222 | 0 |
| K912880 | VITALMAX 510/520 | Pace Tech, Inc. | 1991-11-14 | 136 | 0 |
| K913263 | VITALMAX 830 SERIES | Pace Tech, Inc. | 1991-10-10 | 79 | 0 |
| K905274 | VITALMAX 2100/2200 | Pace Tech, Inc. | 1991-07-17 | 244 | 0 |
| K901066 | VITALMAX 500 PULSE OXIMETER W/TEMP. AND RESPIRA. | Pace Tech, Inc. | 1990-08-28 | 174 | 0 |
| K900451 | VITALMAX 800 NON-INVASIVE VITAL SIGN MONITOR/PULSE | Pace Tech, Inc. | 1990-07-18 | 169 | 0 |
| K901612 | VITALMAX 2000 ECG MONITOR W/NON-INVASIVE BLOOD-PRE | Pace Tech, Inc. | 1990-04-30 | 24 | 0 |
| K900866 | OXIMAX 700 | Pace Tech, Inc. | 1990-04-04 | 40 | 0 |
| K900843 | OXIMAX 100 | Pace Tech, Inc. | 1990-03-28 | 34 | 0 |
| K880351 | VITAL SYSTEM | Pace Tech, Inc. | 1988-03-22 | 56 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda