510(k) K251216
- Device
- 0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line
- Applicant
- Barbaras Development, Inc.
- 510(k) number
- K251216
- Product code
- CCK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-06-04
- Date received
- 2025-04-18
- Regulation
- 868.1400
- Classification name
- Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Matthew Baile
- Address
- 3567 Old Conejo Rd. Newbury Park CA US 91320 91320
FDA Registration Numbers#
- 2936999
- 3011987967
- 3013557562
- 8022257
- 3005873568
- 3033959233
- 3015876
- 9681384
- 3016931915
- 3013679558
- 1062836
- 3006061749
- 3013783488
- 3010390468
- 1319639
- 3007238566
- 3015276780
- 3006547005
- 3007307487
- 3049808762
- 3007207474
- 3032109181
- 3010526986
- 3001570235
- 3003674698
- 9710602
- 3012251275
- 3010882708
- 3013652261
- 3013298431
- 2221819
- 3031887985
- 1000484830
- 3015272694
- 3010703925
- 9611252
- 9710116
- 3006606984
- 3003589956
- 3008806809
- 3009754460
- 3012639025
- 3018783526
- 3007695715
- 3001313714
- 3035111606
- 1526012
- 1000122786
- 9610849
- 3008264255
- 2028807
- 3014479313
- 3009607734
- 3006534321
- 3016618143
- 9616088
- 1417592
- 3013501110
- 3005767446
- 3007481893
- 2320762
- 3006713849
- 8044169
- 3009831876
- 3004748541
- 3017609572
- 2025816
- 2134752
- 3006536657
- 3008483389
- 3030154814
- 3009490946
- 3010419931
- 3004016520
- 9617604
- 3009973336
- 9617566
- 3004415095
- 3006648320
- 3006606827
Source Documents#
Other 510(k) Records For Product Code CCK#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251641 | GF-310R Multigas Unit (GF-310R) | Nihon Kohden Corporation | 2026-08-12 |
| K261633 | VisuBreath | Affirm Medical Technologies II, LLC | 2026-07-14 |
| K253030 | Capnostream™35 Portable Respiratory Monitor (PM35MN) | Covidien, LLC | 2026-05-01 |
| K250148 | Medical Gas Analyzer (AG200) | Prior Care Science Technology, Ltd. | 2025-08-28 |
| K243956 | TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1) | Nihon Kohden Corporation | 2025-06-10 |
| K240937 | AIM (N/A) | Inventeur, LLC | 2024-12-16 |
| K230915 | AirLife™ Open Et Oxygen Mask, AirLife™ Open Et+ Oxygen Mask | Vyaire Medical, Inc. | 2024-11-12 |
| K212425 | MicroTrend System | Exostat Medical, Inc. | 2024-11-07 |
| K222511 | Oxy2Pro | Southmedic, Inc. | 2023-11-21 |
| K213767 | Endure ETCO2/02 Nasal Cannula | Endure Industries, Inc. | 2023-09-12 |
| K221118 | CO2 Mainstream Sensor | Draegerwerk AG & CO Kgaa | 2023-04-05 |
| K210112 | XChange Device, XChange System | Pneuma Therapeutics, Inc. | 2023-01-30 |
| K220533 | Endoscopy Oxygen Mask | Engineered Medical Systems, Inc. | 2022-11-16 |
| K213911 | Microstream CO2 NanoPod | Covidien, LLC | 2022-07-29 |
| K213518 | CARESCAPE CO2 Microstream parameter | Covidien, LLC | 2022-04-12 |