510(k) K071958
- Device
- THERA-HEAT HEATED HUMIDIFIER AND ADULT DUAL AND SINGLE LIMB HEATED WIRE VENTILATOR BREATHING CIRCUITS
- Applicant
- SMITHS MEDICAL ASD, INC.
- 510(k) number
- K071958
- Product code
- BTT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-11-21
- Date received
- 2007-07-16
- Regulation
- 868.5450
- Classification name
- Humidifier, Respiratory Gas, (direct Patient Interface)
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CHRISTINE LLOYD
- Address
- 160 Weymouth St. Rockland MA US 02370 02370
FDA Registration Numbers#
- 9710644
- 2085602
- 3008264065
- 3030308442
- 1625392
- 3013095415
- 3011790297
- 3000126629
- 3010063021
- 3012307300
- 3002797442
- 3008806809
- 3006467300
- 8030673
- 1314417
- 3004111573
- 3023272766
- 9615827
- 2024500
- 3007502289
- 3013820501
- 1417411
- 3014766741
- 3016052406
- 3005440755
- 3006061749
- 3012316249
- 3018783526
- 8043316
- 3009129579
- 3006785496
- 3011987967
- 3008770104
- 9617566
- 3003135857
- 8043439
- 3012971441
- 3043226252
- 1526863
- 3012421607
- 3004604967
- 3001313714
- 3003799815
- 3010476117
- 9616567
- 3043709870
- 3030089838
- 3004365956
- 3017235290
- 3023209222
- 9616874
- 3013557562
- 3007573469
- 3006636961
- 2132517
- 3029906224
- 3011137372
- 3029706818
- 8021995
- 1417592
- 3021947238
- 3008567544
- 2244684
- 9610849
- 3016761372
- 1417519
- 3007238566
- 3017520736
- 3002807267
- 3042226221
- 2523148
- 2028807
- 8010939
- 8010042
- 3021039857
- 1924066
- 3001421318
- 3004748541
- 9611451
Source Documents#
Other 510(k) Records For Product Code BTT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254078 | HVT 2.0 | Vapotherm, Inc. | 2026-04-13 |
| K251448 | FL-10000U Respiratory Humidifier | Flexicare Medical Limited. | 2026-01-16 |
| K251419 | Laboratorios Biogalenic Sterile Water for Inhalation, USP | Laboratorios Biogalenic S.A. DE C.V. | 2026-01-14 |
| K253479 | Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J) | Fisher & Paykel Healthcare, Ltd. | 2025-12-19 |
| K250312 | Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small | Medline Industries, LP | 2025-07-02 |
| K251611 | Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE) | Fisher & Paykel Healthcare, Ltd. | 2025-06-25 |
| K242717 | Laboratorios Biogalenic Sterile Water for Inhalation, USP | Laboratorios Biogalenic S.A. DE C.V. | 2025-01-30 |
| K241778 | Hudson RCI Comfort Flo® CubCannula™ | Medline Industries, LP | 2024-12-19 |
| K240163 | Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula | Medline Industries, LP | 2024-09-27 |
| K234058 | F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J) | Fisher & Paykel Healthcare, Ltd. | 2024-08-08 |
| K233707 | HFT150 | Invent Medical Corporation | 2024-06-14 |
| K233821 | F&P Optiflow Oxygen Kit (AA451J) | Fisher & Paykel Healthcare, Ltd. | 2024-06-13 |
| K222292 | F&P myAirvo 3 | Fisher & Paykel Healthcare | 2024-05-08 |
| K231956 | F&P Optiflow+ Duet Nasal Cannula | Fisher & Paykel Healthcare, Ltd. | 2024-02-07 |
| K230559 | Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260) | Medline Industries, Inc. | 2023-10-26 |
Legacy Summary#
summary
FDA Review#
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