HEMOMETRIX CONTINUOUS BLOOD GAS MONITORING SYSTEM
FDA 510(k) clearance K920061 · decided 1992-03-30
Clearance details
- K-number
- K920061
- Device name
- HEMOMETRIX CONTINUOUS BLOOD GAS MONITORING SYSTEM
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1992-01-07
- Decision date
- 1992-03-30
- Days to decision
- 83 days
- Clearance type
- Traditional
- Product code
- CBZ
- Device class
- 2
- Regulation number
- 868.1170
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Abbott Park, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Abbott Laboratories
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM (K020967) | Terumo Cardiovascular Systems Corp. | 2002-06-20 |
| PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM WITH PARATREND 7 PLUS MULTIPARAMETER SENSOR (K970906) | Diametrics Medical, Ltd. | 1997-09-23 |
| MODEL PB3300 INTRA-ARTER BLOOD GAS MONIT SYS, MODI (K931112) | Puritan Bennett Corp. | 1993-06-01 |
| CDI(TM) 2000 BLOOD GAS MONITORING SYST, MODIFIED (K912030) | 3M Company | 1991-10-30 |
| PB3300 SENSING CATHETER FOR CONTINUOUS MEASUREMENT (K912428) | Puritan Bennett Corp. | 1991-08-09 |
| CDI(R) 2000 BLOOD GAS MONITOR (K884228) | Cardiovascular Devices, Inc. | 1989-01-30 |
| KHURI REGIONAL TISSUE PH MONITOR (K862114) | Vascular Technology Incorporated | 1986-06-25 |
| SENSOMAT MUSCLE/TISSUE PH (K803260) | Biochem International, Inc. | 1981-02-02 |
| SENSOMAT (K803014) | Biochem International, Inc. | 1980-12-22 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ARCHITECT CORE / Alinity i Anti-HBc (P080023/S046) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT AFP / Alinity i AFP (P120008/S030) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S043) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT Total PSA / Alinity i Total PSA (P910007/S066) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT Free PSA / Alinity i Free PSA (P980007/S055) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S052) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory/ Alinity i HBsAg Next Qualitative/Alinity i HBsAg N (P210003/S013) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory (P210003/S012) | Abbott Laboratories | 2024-09-30 |