510(k) K190022
- Device
- SafeBreath Filter Mouthpiece
- Applicant
- MD Diagnostics Limited
- 510(k) number
- K190022
- Product code
- CAH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-09-25
- Date received
- 2019-01-04
- Regulation
- 868.5260
- Classification name
- Filter, Bacterial, Breathing-circuit
- Medical specialty
- Anesthesiology
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Glen Hillsley
- Address
- 15 Hollingworth Ct., Turkey Mill Maidstone GB ME14 5PP ME14 5PP
FDA Registration Numbers#
- 3004050971
- 3010131137
- 3011503227
- 1220253
- 2183585
- 3008693658
- 3017520736
- 3011088743
- 3006157842
- 3010889742
- 3027242374
- 1000604079
- 3005998497
- 3015537026
- 8030673
- 3013187142
- 3009747810
- 3013242701
- 3011137372
- 9680661
- 2529776
- 3004874794
- 3005587132
- 2433214
- 3010877292
- 3006673317
- 2648727
- 3001124136
- 3004428458
- 1924066
- 9616567
- 3003332988
- 3006061749
- 3017174574
- 3012316249
- 3020614
- 3010838917
- 8010042
- 3027977504
- 9710644
- 3007709321
- 2024841
- 3042507287
- 3023294726
- 3004122598
- 8020893
- 3008264065
- 1824226
- 3013530359
- 3000268902
- 3010042047
- 3006534321
- 1024404
- 3009746061
- 3012365569
- 3001313714
- 8044169
- 3013557562
- 3011707784
- 8043316
- 9710567
- 1928237
- 3009896423
- 3006783791
- 3006657376
- 3018116884
- 1055236
- 3004127293
- 3005519819
- 3001104093
- 3017202422
- 3008412416
- 2028807
- 3003862188
- 8040412
- 3004116032
- 3006254047
- 9617604
- 1832562
Source Documents#
Other 510(k) Records For Product Code CAH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252643 | Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled | Teleflex Medical Sdn. Bhd. | 2026-05-15 |
| K251583 | Ambu® Virobac II® Exhalation Filter | Ambu A/S | 2026-04-30 |
| K241339 | Besmed Bacterial Filter and HMEF | Besmed Health Business Corp | 2024-11-14 |
| K222917 | Breathing circuit bacterial/viral filter | Shaoxing Haitech Medical Products Co., Ltd. | 2024-02-15 |
| K230483 | Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15) | Passy-Muir, Inc. | 2023-09-16 |
| K223258 | TNI Clear-Guard™ 3 angled breathing filter (1545020) | Intersurgical , Ltd. | 2023-06-15 |
| K221472 | Filter and HME/Filter | Ningbo Huakun Medical Equipment Co., Ltd. | 2023-02-08 |
| K221836 | Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus | Drägerwerk AG & Co. KGaA | 2022-12-07 |
| K221250 | EasyOne Filter | Ndd Medizintechnik AG | 2022-11-22 |
| K210352 | GGM Breathing Circuit Bacterial Filter | Great Group Medical Co, Ltd. | 2022-03-27 |
| K211286 | Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger | Pall Corporation | 2021-11-16 |
| K202459 | Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-HME HME/Filter and Bact-HME Midi HME/Filter | Pharma System AB | 2021-09-26 |
| K191909 | HepaShield Bacterial Viral Breathing System Filter | Flexicare Medical Limited. | 2020-03-23 |
| K192713 | Altera Filter and HME/Filter | Meditera Tibbi Malzeme San VE Tic AS | 2020-03-16 |
| K182862 | Servo Guard | Maquet Critical Care AB | 2019-10-21 |
Legacy Summary#
summary
FDA Review#
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