510(k) · Cleared
ClearedWeinmanncompact, Model WM 27380; WEINMANNCLICK2, Model WM 27340
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Weinmann Gerate Fur Medizin GmbH + Co. KG · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Dec 14, 2007 as substantially equivalent to K013909 (Resmed Corp, 2002) and 1 other predicate after a 144-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Dec 14, 2007
- Review
- 144 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K971260 (1997). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK971260 Sullivan Humidaire Heated HumidifierResmed Corp · 1997
- 2 generations backK013909 S7 Elite CP AP SystemResmed Corp · 2002
- 1 generation backK071163 Weinmanncomfort 2, Model WM 27600 and Weinmannaqua, Model WM 27603Weinmann Gerate Fur Medizin GmbH + Co. KG · 2007
- This deviceK072009 Weinmanncompact, Model WM 27380; WEINMANNCLICK2, Model WM 27340Weinmann Gerate Fur Medizin GmbH + Co. KG · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K971260 | Sullivan Humidaire Heated Humidifier | Resmed Corp | 1997 | — |
| −2 | K013909 | S7 Elite CP AP System | Resmed Corp | 2002 | — |
| −1 | K071163 | Weinmanncomfort 2, Model WM 27600 and Weinmannaqua, Model WM 27603 | Weinmann Gerate Fur Medizin GmbH + Co. KG | 2007 | — |
| 0 (this device) | 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 |
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
What was it cleared against? (2)
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 | Decided |
|---|---|---|---|
| * | K013909 | S7 Elite CP AP SystemSummary page 1…905, Class II, Product Code BZD Predicate Device Equivalence: Substantial equivalence is claimed to ResMed S7 Elite CPAP System, cleared for commercial distribution per K013909 and WEINMANNcomfort 2, cleared for commercial distribution (since the original submittal) per K071163. Device Description: The W… | 2002 |
| * | K071163 | Weinmanncomfort 2, Model WM 27600 and Weinmannaqua, Model WM 27603Summary page 1…esMed S7 Elite CPAP System, cleared for commercial distribution per K013909 and WEINMANNcomfort 2, cleared for commercial distribution (since the original submittal) per K071163. Device Description: The WEINMANNcompact is a microprocessor controlled blower-based device that generates a Continuous Positive… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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 4.8 years on median.
- None of the 4 ancestors has a recall.
- 6 other devices also cite its predicate K013909.
How does its category compare?
All BZD devicesBZD 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
2026 to Oct 25, outlined.
Median 510(k) review, days · BZD
189in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BZD
8in 2023
Class I (13 since 2007) Class II/III not classified
Adverse event reports per year · BZD
60,279in 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?
WEINMANNcompact is for the treatment of Obstructive Sleep Apnea (OSA) in adult patients (>30kg). The device delivers a fixed therapy pressure within the range of 4 to 20 cmH20. The optional humidifier (WEINMANNclick 2) is indicated for the humidification and warming of air from the WEINMANNcompact flow generator device. The WEINMANNcompact and WEINMANNclick 2 are for home and hospital use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072009 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072009: Weinmanncompact, Model WM 27380; WEINMANNCLICK2, Model WM 27340.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072009
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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