510(k) K252643
- Device
- Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled
- Applicant
- Teleflex Medical Sdn. Bhd.
- 510(k) number
- K252643
- Product code
- CAH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-05-15
- Date received
- 2025-08-21
- Regulation
- 868.5260
- Classification name
- Filter, Bacterial, Breathing-Circuit
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Suguneswary Subramaniam
- Address
- Lot Pt. 2577 Jalan Perusahaan 4 Kamunting MY 34600 34600
FDA Registration Numbers#
- 9680661
- 3003898360
- 3011987967
- 3042507287
- 8010042
- 3009887154
- 3009747810
- 2024841
- 3011088743
- 3011503227
- 3012821221
- 3005587132
- 9680602
- 9614485
- 3010834934
- 2518443
- 9617604
- 3020777588
- 3017202422
- 9681848
- 2529776
- 3018094310
- 3017987980
- 3010889742
- 8030673
- 3015134079
- 1054241
- 3009171251
- 1928237
- 8021995
- 3017174574
- 3009896423
- 1824226
- 9611500
- 3000268902
- 3017520736
- 3001313714
- 9710644
- 3006606984
- 3015191173
- 3011707784
- 1832562
- 3008264065
- 3006419626
- 1024404
- 3021244152
- 1055236
- 3010402691
- 2183585
- 3003399703
- 3006446479
- 3003862188
- 1220253
- 3008806809
- 9611451
- 3010439239
- 3014936217
- 3004127293
- 3008567544
- 3003697063
- 2936999
- 3004116032
- 3005012805
- 3004050971
- 3004365956
- 3005855942
- 1526863
- 3013187142
- 3001104093
- 3005515211
- 3010838917
- 3012316249
- 1043214
- 2320762
- 8043316
- 3006783791
- 3023294726
- 8044169
- 3010877292
Source Documents#
Other 510(k) Records For Product Code CAH#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K190022 | SafeBreath Filter Mouthpiece | MD Diagnostics Limited | 2019-09-25 |