510(k) K251448

Device: FL-10000U Respiratory Humidifier
Applicant: Flexicare Medical Limited.
510(k) number: K251448
Product code: BTT
Decision: Substantially Equivalent (SESE)
Decision date: 2026-01-16
Date received: 2025-05-09
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: N

Related Records

Applicant Contact

Contact: Rebecca Funston
Address: Cynon Valley Business Park Mountain Ash. Cf45 4er. Rhondda Cynon Taf GB CF45 4ER CF45 4ER

FDA Registration Numbers

3010272829
9680661
3016052406
3021947238
3003898360
3011987967
3014766741
3006636961
3042507287
8010042
1423662
1417411
3011971979
3005587132
3018900343
3007502289
3018094310
8030673
8043439
9617566
3018783526
8021995
3029906224
9611500
3043709870
3017520736
3001313714
9710644
3006606984
3029706818
1417519
3030089838
3008264065
3011120183
3007238566
3021039857
3008770104
3004111573
3016723884
3012971441
3008806809
9610849
3009129579
9611451
3010063021
3017235290
3008567544
3043226252
3004050971
3004365956
1526863
3004604967
1420032
3013820501
3014499739
3006785496
3023272766
3012316249
8043316
3006783791
2244684
3004748541
3013095415
1225492
2028807
2518422
3030149975
8010939
1417592
3006467300
3015537026
1625392
2523148
3006061749
2132517
3016761372
3023209222
3012494290
9710641

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code BTT

510(k)	Device	Applicant	Decision date
K254078	HVT 2.0	Vapotherm, Inc.	2026-04-13
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
K223863	BONHAWA Respiratory Humidifier	Telesair, Inc.	2023-10-13