510(k) · Cleared

Cleared

Water Chambers for ST 3000 Heated Humidifier

K962223510(k) TraditionalCleared Jan 14, 1997218-day reviewClass II21 CFR 868.5450

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Marquest Medical Products, Inc. · BTT Humidifier, Respiratory Gas, (Direct Patient Interface)

Cleared on Jan 14, 1997 as substantially equivalent to K864173 (Hpd Medical, Inc., 1987) and 3 other predicates after a 218-day review. Its family tree reaches back 1 generation to 1985. 1 later device descends from it.

Decided: Jan 14, 1997
Review: 218 days
Class: Class II
Product code: BTT
Recalls: None
Predicates: 5

Its longest line of descent runs back 1 generation to K850647 (1985). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK850647 Heated Respiratory Humififier MR440Fisher & Paykel Allied Products, Ltd. · 1985
This deviceK962223 Water Chambers for ST 3000 Heated HumidifierMarquest Medical Products, Inc. · 1997
Descendant · cites it directly · 0 of its ownK993282 Ipi Humidifier ChamberI.P.I. Medical Products · 2000

Most influential descendants

Showing 1 of 1 · See all

K993282Ipi Humidifier ChamberI.P.I. Medical Products · 2000 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K850647	Heated Respiratory Humififier MR440	Fisher & Paykel Allied Products, Ltd.	1985	—
0 (this device)	K962223	Water Chambers for ST 3000 Heated Humidifier	Marquest Medical Products, Inc.	1997	—
+1	K993282	Ipi Humidifier Chamber	I.P.I. Medical Products	2000	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1986	1	0
1987	1	0
1994	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0

FIG. 1 — Lineage of K962223, 1985–2000Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in BTT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new BTT device

#1 K222197 F&P Optiflow Junior 2/2+ Nasal Cannula…score 16.8 · 10 generations · no Class I recall
#2 Held for the reportin the report
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What was it cleared against? (5)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
Kept off the family tree	K903138	FDA’s K903138 is Marquest SCT 3000, Heated Humidification System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree	Marquest Medical Products, Inc.	1990	—
*	K864173	HPD Humidifying Chamber Summary page 1 …interface) Subsection 868.5450 Intended device: Humidifier chambers for use with SCT 3000 Heated Humidifier Predicate devices: Marquest SCT 3000 - K303138 HPD Medical - K864173 Fisher & Paykel - K850647, K862923, K934140 Device description: The humidifier chambers offered for use with the SCT 3000. * Adu…	Hpd Medical, Inc.	1987	—
*	K850647	Heated Respiratory Humififier MR440 Summary page 1 …5450 Intended device: Humidifier chambers for use with SCT 3000 Heated Humidifier Predicate devices: Marquest SCT 3000 - K303138 HPD Medical - K864173 Fisher & Paykel - K850647, K862923, K934140 Device description: The humidifier chambers offered for use with the SCT 3000. * Adult - low flow humidifier c…	Fisher & Paykel Allied Products, Ltd.	1985	—
*	K862923	MR620 Dual Servo Heated Anaesthesia Humidifier Summary page 1 …nded device: Humidifier chambers for use with SCT 3000 Heated Humidifier Predicate devices: Marquest SCT 3000 - K303138 HPD Medical - K864173 Fisher & Paykel - K850647, K862923, K934140 Device description: The humidifier chambers offered for use with the SCT 3000. * Adult - low flow humidifier chamber *…	Fisher & Paykel Allied Products, Ltd.	1986	—
*	K934140	MR290 Humidification Chamber Single Use Summary page 1 …ce: Humidifier chambers for use with SCT 3000 Heated Humidifier Predicate devices: Marquest SCT 3000 - K303138 HPD Medical - K864173 Fisher & Paykel - K850647, K862923, K934140 Device description: The humidifier chambers offered for use with the SCT 3000. * Adult - low flow humidifier chamber * Adult - e…	Fisher & Paykel Electronics, Ltd.	1994	—

Also cleared against K864173: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K993282	Ipi Humidifier Chamber	I.P.I. Medical Products	2000	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 4 ancestors has a recall.
Of its descendants, K993282 (I.P.I. Medical Products, 2000) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K864173.

How does its category compare?

All BTT devices

BTT Humidifier, Respiratory Gas, (Direct Patient Interface): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BTT

4in 2025

2007high 7 (2014) · low 1 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BTT

104in 2025

2007high 303 (2017) · low 73 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · BTT

1in 2025

2007high 5 (2014) · low 0 (2009)2026

Class I (4 since 2007) Class II/III not classified

Adverse event reports per year · BTT

1,743in 2025

2007high 1,743 (2025) · low 365 (2007)2025

MAUDE reports naming product code BTT, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	6	73	1	365
2008	4	199	1	456
2009	1	—	0	558
2010	4	113	2	562
2011	3	116	1	665
2012	2	—	0	583
2013	6	171	0	718
2014	7	231	5 (4)	718
2015	1	—	0	670
2016	3	157	0	1,094
2017	3	303	0	1,007
2018	2	—	0	918
2019	1	—	0	894
2020	2	—	0	1,188
2021	2	—	0	1,510
2022	3	290	0	749
2023	7	258	0	716
2024	7	219	0	501
2025	4	104	1	1,743
2026	4	184	1	—

What is it indicated for?

The humidifier chambers for the SCT 3000 are indicated for use with the SCT 3000 unit and to hold water required to humidify the air being delivered to patients.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K962223 · printed Nov 6, 2026

Cite this page

510(k) Report. “K962223: Water Chambers for ST 3000 Heated Humidifier.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962223

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026