510(k) K251326
- Device
- Respiration Rate algorithm
- Applicant
- Edwards Lifesciences, LLC
- 510(k) number
- K251326
- Product code
- BZQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-06-11
- Date received
- 2025-04-29
- Regulation
- 868.2375
- Classification name
- Monitor, Breathing Frequency
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Manthan Damani
- Address
- One Edwards Way Irvine CA US 92614 92614
FDA Registration Numbers#
- 3010097171
- 3030284974
- 3004748541
- 8022257
- 3011235999
- 3003263092
- 3012307300
- 3006157842
- 1824206
- 3010272829
- 3015282442
- 1651104
- 3006125362
- 3012528160
- 3012933969
- 3006606984
- 2011171
- 3020018
- 3016595211
- 3030733800
- 3026751377
- 3005783425
- 2518422
- 3044754336
- 3006979678
- 3027256461
- 3020277584
- 3033715634
- 3016701404
- 3017760831
- 3027510187
- 3008483389
- 3017812398
- 3013500228
- 3014579161
- 3018783526
- 3008058135
- 3000126629
- 3014739036
- 8020893
- 9680215
- 3003174284
- 3023146633
- 3009831876
- 3032109181
- 2025694
- 9612330
- 2936999
- 9610849
- 3007305624
- 3023272766
- 3006240053
- 3015134004
- 3010838917
- 3018094310
- 9610816
- 2183613
- 3016931915
- 3012359877
- 3016674095
- 3005877899
- 1066427
- 1000122786
- 3010390468
- 3008729547
- 3000130829
- 3013679558
- 3020207731
- 1223925
- 3013572357
- 3015455735
- 3023412068
- 3009973336
- 2029015
- 3009077524
- 1320894
- 3009351773
- 1316463
- 9610105
- 3032906215
Source Documents#
Other 510(k) Records For Product Code BZQ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253274 | BedDot (G1) | Intelligent Dots, LLC | 2026-06-25 |
| K250093 | Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) | Linshom Medical, Inc. | 2025-09-26 |
| K250934 | Respiree Cardio- Respiratory Monitor System | Respiree Pte, Ltd. | 2025-08-05 |
| K243183 | RTMsense Respiratory Monitoring System | Rtm Vital Signs, LLC | 2025-06-27 |
| K243966 | FaceHeart Vitals Software Development Kit (FH vitals SDK-RR) | Faceheart Corp. | 2025-04-09 |
| K242001 | Philips VSC-MEDlib | Philips Medical Systems Nederland B.V. | 2025-04-04 |
| K233953 | Makani Science™ Respiration Monitoring System | Makani Science, Inc. | 2025-03-28 |
| K242798 | Airmod | Heroic Faith International , Ltd. | 2025-02-28 |
| K240271 | Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) | Linshom Medical, Inc. | 2024-09-11 |
| K223681 | Respiree Cardio-Respiratory Monitor | Respiree Pte, Ltd. | 2023-03-08 |
| K221555 | Dozee VS | Turtle Shell Technologies Private Limited | 2022-12-15 |
| K223246 | Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense | Baxter Healthcare Corproration | 2022-11-18 |
| K220111 | RespiraSense | Pmd Solutions | 2022-10-07 |
| K211387 | Breathe Easy Mobile Respiratory Monitor (MRM) | Sound Life Sciences, Inc. | 2021-11-23 |
| K202018 | Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Packs, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Activation | Hill-Rom, Inc. | 2021-03-04 |