510(k) · Cleared

Cleared

Heated Wire Circuits for SCT 3000 Heated Humidifier

K962220510(k) TraditionalCleared Jan 14, 1997218-day reviewClass II21 CFR 868.5270

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. · BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

Cleared on Jan 14, 1997 as substantially equivalent to K903138 (Marquest Medical Products, Inc., 1990) and 2 other predicates after a 218-day review. Its family tree reaches back 1 generation to 1986. 1 later device descends from it.

Decided: Jan 14, 1997
Review: 218 days
Class: Class II
Product code: BZE
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K860941 (1986). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK860941 Disposable Heated Wire Loops 48 and 72Intec Medical, Inc. · 1986
This deviceK962220 Heated Wire Circuits for SCT 3000 Heated HumidifierMarquest Medical Products, Inc. · 1997
Descendant · cites it directly · 0 of its ownK993268 Mallinckrodt Dar Heated Wire Breathing CircuitMallinckrodt Dar S.R.L. · 2000

Most influential descendants

Showing 1 of 1 · See all

K993268Mallinckrodt Dar Heated Wire Breathing CircuitMallinckrodt Dar S.R.L. · 2000 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K860941	Disposable Heated Wire Loops 48 and 72	Intec Medical, Inc.	1986	—
0 (this device)	K962220	Heated Wire Circuits for SCT 3000 Heated Humidifier	Marquest Medical Products, Inc.	1997	—
+1	K993268	Mallinckrodt Dar Heated Wire Breathing Circuit	Mallinckrodt Dar S.R.L.	2000	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1988	1	0
1990	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0

FIG. 1 — Lineage of K962220, 1986–2000Source: 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 BZE? 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 BZE device

#1 K252066 inspired™ Heated Breathing Circuit (510-008)…score 13.3 · 7 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (3)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K903138	Marquest SCT 3000, Heated Humidification System Our OCR of the scanned summary read K503138, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Marquest SCT 3000”.	Marquest Medical Products, Inc.	1990	—
*	K860941	Disposable Heated Wire Loops 48 and 72 Summary page 1 …n 868.5270 - Intended device: Breathing circuits for use with SCT 3000 Heated Humidifier Predicate devices: Marquest SCT 3000 - KS03138 Marquest (Intec) - Heated limb - K860941 Intertech ( SIMS) - K881231 Device description: Various configurations of anesthesia, volume ventilator circuits and heated limb…	Intec Medical, Inc.	1986	—
*	K881231	Dabc Nonconductive Heated Anesth. Breath. Circuit Summary page 1 …: Breathing circuits for use with SCT 3000 Heated Humidifier Predicate devices: Marquest SCT 3000 - KS03138 Marquest (Intec) - Heated limb - K860941 Intertech ( SIMS) - K881231 Device description: Various configurations of anesthesia, volume ventilator circuits and heated limbs for use with SCT 3000 Heat…	Intertech Resources, Inc.	1988	—

Also cleared against K903138: 2 other devices →

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
K993268	Mallinckrodt Dar Heated Wire Breathing Circuit	Mallinckrodt Dar S.R.L.	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 3 ancestors has a recall.
Of its descendants, K993268 (Mallinckrodt Dar S.R.L., 2000) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K903138.

How does its category compare?

All BZE devices

BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BZE

1in 2025

2007high 5 (2016) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BZE

241in 2016

2007high 241 (2016)2026

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

Recalls per year · BZE

No recall names BZE since 2007.

Adverse event reports per year · BZE

193in 2025

2007high 387 (2013) · low 69 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	69
2008	0	—	74
2009	0	—	80
2010	2	—	126
2011	1	—	192
2012	2	—	334
2013	0	—	387
2014	1	—	338
2015	1	—	155
2016	5	241	214
2017	1	—	209
2018	1	—	103
2019	0	—	134
2020	0	—	123
2021	1	—	124
2022	0	—	152
2023	1	—	125
2024	2	—	172
2025	1	—	193
2026	2	—	—

What is it indicated for?

Heated wire circuits to be used with the SCT 3000 are indicated as breathing circuits for patients under going anesthesia or mechanical ventilation.

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/K962220 · printed Nov 5, 2026

Cite this page

510(k) Report. “K962220: Heated Wire Circuits for SCT 3000 Heated Humidifier.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K962220

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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