Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Criticare Systems, Inc. — Predicate Candidate Screening
22 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
100 daysmedian FDA review time
260 days90th percentile
22clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K101602 | VITAL SIGNS MONITOR | Criticare Systems, Inc. | 2010-09-01 | 85 | 0 |
| K091050 | 506CN PATIENT MONITOR | Criticare Systems, Inc. | 2009-05-27 | 44 | 0 |
| K042569 | 8600 VITAL SIGNS MONITOR | Criticare Systems, Inc. | 2004-09-29 | 8 | 3 |
| K030613 | VITAL SIGNS MONITOR W/ARRHYTHMIA DETECTION AND ST ANALYSIS, | Criticare Systems, Inc. | 2003-04-17 | 50 | 0 |
| K022435 | 507EL VITAL SIGNS MONITOR | Criticare Systems, Inc. | 2002-08-14 | 20 | 0 |
| K012059 | 8100/8500 VITAL SIGNS MONITOR | Criticare Systems, Inc. | 2001-08-01 | 30 | 0 |
| K001020 | 8100 VITAL SIGNS MONITOR | Criticare Systems, Inc. | 2000-04-28 | 29 | 0 |
| K000276 | MPT 24 AND VITAL VIEW 24 | Criticare Systems, Inc. | 2000-03-01 | 30 | 0 |
| K961223 | MULTIPLE PARAMETER TELEMETRY, VITAL VIEW, & MICROVIEW SYSTEM | Criticare Systems, Inc. | 1996-12-10 | 256 | 0 |
| K944860 | SCHOLAR PATIENT MONITOR | Criticare Systems, Inc. | 1995-06-20 | 260 | 0 |
| K942737 | POET IQ WITH FIVE AGENT CAPABILITY | Criticare Systems, Inc. | 1995-02-09 | 244 | 0 |
| K921309 | MODEL 508 PATIENT MONITOR | Criticare Systems, Inc. | 1993-12-17 | 647 | 0 |
| K910852 | 507 NON-INVASIVE VITAL SIGNS MONITOR | Criticare Systems, Inc. | 1991-07-30 | 153 | 0 |
| K911124 | 503 PULSE OXIMETER | Criticare Systems, Inc. | 1991-06-07 | 87 | 0 |
| K910770 | 504US PULSE OXIMETER | Criticare Systems, Inc. | 1991-05-14 | 81 | 0 |
| K884643 | 1100 VITAL SIGNS MONITOR | Criticare Systems, Inc. | 1989-10-30 | 357 | 0 |
| K892854 | ANESTHETIC AGENT MONITOR | Criticare Systems, Inc. | 1989-10-13 | 178 | 0 |
| K884216 | 506 NON-INVASIVE VITAL SIGNS MONITOR | Criticare Systems, Inc. | 1989-03-16 | 161 | 0 |
| K875298 | 502-US PULSE OXIMETER | Criticare Systems, Inc. | 1988-03-07 | 68 | 0 |
| K864745 | POET OXIMETER | Criticare Systems, Inc. | 1987-06-02 | 179 | 0 |
| K864613 | 502 OXYGEN SATURATION MONITOR | Criticare Systems, Inc. | 1987-03-04 | 100 | 0 |
| K853331 | OSM-1 OXYGEN SATURATION MONITOR | Criticare Systems, Inc. | 1986-01-14 | 159 | 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