RESIDENT BEDSIDE MONITOR
FDA 510(k) clearance K811216 · decided 1981-07-02
Clearance details
- K-number
- K811216
- Device name
- RESIDENT BEDSIDE MONITOR
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1981-05-04
- Decision date
- 1981-07-02
- Days to decision
- 59 days
- Clearance type
- Traditional
- Product code
- DRT
- Device class
- 2
- Regulation number
- 870.2300
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Abbott Park, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| The Circadia C300 System (C300) (K261286) | Circadia Health, Inc. | 2026-05-20 |
| The Circadia C300 System (C300) (K252676) | Circadia Health, Inc. | 2026-02-03 |
| Sleepiz One+ (Model 2.5) (K253388) | Sleepiz AG | 2026-01-28 |
| Sleepiz One+ (2.5) (K251364) | Sleepiz AG | 2025-07-29 |
| The Circadia C200 System (K234003) | Circadia Technologies, Ltd. | 2024-05-30 |
| Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software (K232354) | Murata Vios, Inc. | 2024-03-22 |
| Neteera 130H-Plus Vital Sign Monitoring Sensor (K231733) | Neteera Technologies , Ltd. | 2024-02-09 |
| Sleepiz One+ (K223163) | Sleepiz AG | 2023-08-18 |
| Neteera 130H/131H Vital Sign Monitoring Sensor (K212143) | Neteera Technologies , Ltd. | 2022-09-28 |
| Cardiac Trigger Monitor (K202138) | Ivy Biomedical Systems, Inc. | 2021-05-14 |
| Vital Sign Monitoring Sensor (Model :XK300) (K202464) | Xandar Kardian, Inc. | 2021-04-26 |
| Philips wearable biosensor-G5 Solution (K181165) | Connected Sensing- A Division of Philips Medical Systems | 2019-03-07 |
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 |