Criticare Technologies, Inc.
FDA Regulatory Profile
Criticare Technologies, Inc. appears in FDA public data with 1 recall, 1 510(k) clearance, 5 FDA inspections, and 2 compliance actions on record. Its most recent recall (Z-3253-2026, Class II) was initiated on May 6, 2026. Its most recent 510(k) clearance was granted on Jun 9, 1986.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 1
- Inspections
- 5
- Compliance Actions
- 2
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-3253-2026 | Class II | nGenuity Patient Monitor with Capnography (ETCO2) CAT 8100E1-ST-US, CAT 8100E1-US, CAT 8100EP1, C | May 6, 2026 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K861324 | PATIENTCARE 1000 | Jun 9, 1986 |