510(k) K162553
- Device
- AirSpiral Heated Breathing Tube
- Applicant
- FISHER & PAYKEL HEALTHCARE
- 510(k) number
- K162553
- Product code
- BZE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-12-20
- Date received
- 2016-09-13
- Regulation
- 868.5270
- Classification name
- Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- STEPHANIE ELVIN
- Address
- 15 Maurice Paykel Pl., E. Tamaki Auckland NZ 2013 2013
FDA Registration Numbers#
- 3004050971
- 3012421607
- 8010939
- 3017520736
- 3030446844
- 1417411
- 3005998497
- 3015537026
- 8030673
- 3011120183
- 3011137372
- 3010817335
- 9680661
- 3005587132
- 3021039857
- 3018900343
- 9616567
- 1924066
- 3016450067
- 3006061749
- 3006467300
- 3008770104
- 3012316249
- 9617566
- 8010042
- 3015928685
- 9710644
- 3021947238
- 1417592
- 3042507287
- 3029706818
- 3001421318
- 3010272829
- 9610849
- 3008264065
- 3042226221
- 3005440755
- 1423662
- 3001313714
- 3043226252
- 2244684
- 1225492
- 3016723884
- 3003135857
- 3013557562
- 3030089838
- 3014766741
- 3017235290
- 8043316
- 3030308442
- 3016052406
- 3006783791
- 3023209222
- 3013820501
- 2028807
- 3002797442
- 3023272766
- 8043439
- 3011971979
- 1417519
- 2085602
- 3007238566
- 3012494290
- 3007502289
- 3030149975
- 3014499739
- 3044994756
- 3003799815
- 3009129579
- 8021995
- 3003898360
- 1420032
- 2523148
- 3004111573
- 3008806809
- 9611500
- 3012307300
- 3006785496
- 3012971441
- 3002807267
Source Documents#
Other 510(k) Records For Product Code BZE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253322 | Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78” Infant Circuit, HUD99060KIT / Dri-Tech with 78” Infant Circuit Kit, HUD99001KIT / Single Limb Infant Circuit Dri-Tech Kit, HUD99009KIT / Dri-Tech with 60” Infant Circuit Kit, HUD99018KIT / Dri-Tech with 44” Infant Circuit Kit, HUD870NKIT / Dri-Tech Infant Accessory Bag, HUD1631 / Infant Wye Connector with Swivel) | Medline Industries, LP | 2026-03-25 |
| K243244 | Heated Breathing Tube | Guangdong Eda Technology Co., Ltd. | 2025-07-25 |
| K241268 | Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS) | Exceleron Medical | 2024-08-02 |
| K234032 | Hudson RCI Dri-Tech Breathing Circuits; HUD99035/Dri-Tech Adult Circuit; HUD99035KIT/Dri-Tech Adult Circuit Kit; HUD99098KIT/Single Limb Adult Dri-Tech Kit; HUD99098KITF/Single Limb Adult Dri-Tech Filter Kit; HUD900/Dri-Tech Ventilator Accessory; HUD901/Dri-Tech Ventilator Accessory Extension Line | Medline Industries, LP | 2024-06-04 |
| K222822 | VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608) | Draegerwerk AG & CO Kgaa | 2023-06-14 |
| K201418 | Sunset Heated CPAP Tube | Sunset Healthcare Solutions, Inc. | 2021-01-29 |
| K173280 | Neonatal ConchaSmart Breathing Circuits | Teleflexmedical, Inc. | 2018-08-02 |
| K170378 | AirLife Adult Heated Wire BiPAP/NIV Circuit | Vyaire Medical | 2017-09-14 |
| K153234 | AirLife Adult Heated Wire Circuit | Carefusion, Inc. | 2016-07-07 |
| K160540 | FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM | Flexicare Medical Limited. | 2016-06-23 |
| K151461 | Hybernite RT | Plastiflex Group NV | 2016-03-24 |
| K151303 | AirLife Infant Heated Wire Circuit | Care Fusion | 2016-01-21 |
| K151959 | AirLife Infant Single Limb Heated Wire Circuit | Carefusion, Inc. | 2016-01-20 |
| K150900 | Flexicare Heated Wire Breathing Systems | Flexicare Medical, Ltd. | 2015-05-15 |
| K140424 | RESPIRONICS REUSABLE HEATED TUBING | Respironics, Inc. | 2014-11-14 |
Legacy Summary#
summary
FDA Review#
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