510(k) · Cleared

Cleared

Weinmanncomfort 2, Model WM 27600 and Weinmannaqua, Model WM 27603

K071163510(k) TraditionalCleared Jul 18, 200783-day reviewClass II21 CFR 868.5905

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

Weinmann Gerate Fur Medizin GmbH + Co. KG · BZD Ventilator, Non-Continuous (Respirator)

Cleared on Jul 18, 2007 as substantially equivalent to K013909 (Resmed Corp, 2002) after an 83-day review. Its family tree reaches back 2 generations to 1997. 1 later device descends from it.

Decided: Jul 18, 2007
Review: 83 days
Class: Class II
Product code: BZD
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K971260 (1997). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 2 generations backK971260 Sullivan Humidaire Heated HumidifierResmed Corp · 1997
1 generation backK013909 S7 Elite CP AP SystemResmed Corp · 2002
This deviceK071163 Weinmanncomfort 2, Model WM 27600 and Weinmannaqua, Model WM 27603Weinmann Gerate Fur Medizin GmbH + Co. KG · 2007
Descendant · cites it directly · 0 of its ownK072009 Weinmanncompact, Model WM 27380; WEINMANNCLICK2, Model WM 27340Weinmann Gerate Fur Medizin GmbH + Co. KG · 2007

Most influential descendants

Showing 1 of 1 · See all

K072009Weinmanncompact, Model WM 27380; WEINMANNCLICK2, Model WM 27340Weinmann Gerate Fur Medizin GmbH + Co. KG · 2007 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K971260	Sullivan Humidaire Heated Humidifier	Resmed Corp	1997	—
−1	K013909	S7 Elite CP AP System	Resmed Corp	2002	—
0 (this device)	K071163	Weinmanncomfort 2, Model WM 27600 and Weinmannaqua, Model WM 27603	Weinmann Gerate Fur Medizin GmbH + Co. KG	2007	—
+1	K072009	Weinmanncompact, Model WM 27380; WEINMANNCLICK2, Model WM 27340	Weinmann Gerate Fur Medizin GmbH + Co. KG	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0

FIG. 1 — Lineage of K071163, 1997–2007Source: 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 BZD? 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 BZD device

#1 K250624 myAirscore 15.7 · 12 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? (1)

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
*	K013909	S7 Elite CP AP System Summary page 1 ….5905, Class II,Product Code BZD Predicate Device Equivalence: Substantial equivalence is claimed to ResMed S7 Bite CPAP System, cleared for commercial distribution per K013909. Device Description: The WEINMANNcomfort 2 is a microprocessor controlled blower-based device that generates a Continuous Posit…	Resmed Corp	2002	—

Also cleared against K013909: 6 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
K072009	Weinmanncompact, Model WM 27380; WEINMANNCLICK2, Model WM 27340	Weinmann Gerate Fur Medizin GmbH + Co. KG	2007	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?

The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 5.0 years on median.
None of the 3 ancestors has a recall.
Of its descendants, K072009 (Weinmann Gerate Fur Medizin GmbH + Co. KG, 2007) has gone furthest, with 0 descendants of its own.
6 other devices also cite its predicate K013909.

How does its category compare?

All BZD devices

BZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · BZD

7in 2025

2007high 23 (2009) · low 4 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BZD

189in 2025

2007high 280 (2018) · low 83 (2007)2026

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

Recalls per year · BZD

8in 2023

2007high 29 (2007) · low 0 (2010)2026

Class I (13 since 2007) Class II/III not classified

Adverse event reports per year · BZD

60,279in 2025

2007high 90,768 (2022) · low 65 (2007)2025

MAUDE reports naming product code BZD, 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	21	83	29	65
2008	17	108	2	67
2009	23	90	1	147
2010	12	122	0	143
2011	23	125	1	189
2012	21	133	0	139
2013	23	127	0	82
2014	14	172	0	86
2015	11	224	0	114
2016	12	217	0	118
2017	5	221	0	148
2018	5	280	0	101
2019	6	231	4 (4)	188
2020	6	137	0	126
2021	6	192	0	6,066
2022	4	253	0	90,768
2023	5	204	8 (7)	27,987
2024	10	132	0	68,262
2025	7	189	0	60,279
2026	10	214	2 (2)	—

What is it indicated for?

The WEINMANNcomfort 2 is for the treatment of Obstructive Sleep Apnea (OSA) in adult patients. The optional integrated humidifier (WEINMANNaqua) is indicated for the humidification and warming of air from the WEINMANNcomfort 2 flow generator device. The WEINMANNcomfort 2 and WEINMANNaqua are for home and hospital use.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K071163 · printed Nov 5, 2026

Cite this page

510(k) Report. “K071163: Weinmanncomfort 2, Model WM 27600 and Weinmannaqua, Model WM 27603.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071163

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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