Criticare Systems, Inc.: FDA filings under this applicant name
FDA lists 22 510(k) clearances under the applicant name “Criticare Systems, Inc.” (first 1986, latest 2010), across 13 product codes in 2 review panels. Median 510(k) review time under this name: 94 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 | 4 | 4 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 3 | 3 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 3 | 3 |
| DSI | Detector And Alarm, Arrhythmia | 2 | 2 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 2 | 2 |
| BTY | Calculator, Predicted Values, Pulmonary Function | 1 | 1 |
| CBQ | Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | 1 | 1 |
| CBS | Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | 1 | 1 |
| DQE | Catheter, Oximeter, Fiber-Optic | 1 | 1 |
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 1 | 1 |
Plus 3 more product codes.
Review panels
- Cardiovascular (14)
- Anesthesiology (7)
Most recent Criticare Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K101602 | VITAL SIGNS MONITOR | MLD | 2010-09-01 | 85 |
| K091050 | 506CN PATIENT MONITOR | DRT | 2009-05-27 | 44 |
| K042569 | 8600 VITAL SIGNS MONITOR | MWI | 2004-09-29 | 8 |
| K030613 | VITAL SIGNS MONITOR W/ARRHYTHMIA DETECTION AND ST ANALYSIS, MODEL 8100 | MHX | 2003-04-17 | 50 |
| K022435 | 507EL VITAL SIGNS MONITOR | DRT | 2002-08-14 | 20 |
| K012059 | 8100/8500 VITAL SIGNS MONITOR | MWI | 2001-08-01 | 30 |
| K001020 | 8100 VITAL SIGNS MONITOR | MWI | 2000-04-28 | 29 |
| K000276 | MPT 24 AND VITAL VIEW 24 | DRG | 2000-03-01 | 30 |
| K961223 | MULTIPLE PARAMETER TELEMETRY, VITAL VIEW, & MICROVIEW SYSTEMS | LOS | 1996-12-10 | 256 |
| K944860 | SCHOLAR PATIENT MONITOR | MHX | 1995-06-20 | 260 |
12 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Criticare Systems, 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.
- Criticare Technologies Corp. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Criticare Systems, Inc.?
FDA lists 22 510(k) clearances under the applicant name “Criticare Systems, Inc.” (first 1986, latest 2010), across 13 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 Criticare Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Criticare Systems, Inc. is 94 days.
Which FDA product codes appear under Criticare Systems, Inc.?
The most frequent FDA product codes under this applicant name are DQA (Oximeter, 4); DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), 3); MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms), 3).
Next steps
- See all 22 Criticare Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQA, Criticare Systems, 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.