510(k) · Cleared
ClearedSlumbergear (TM), Model Multiple (004, 005, 005, 007)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Suiter Enterprises, Inc. · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Sep 10, 2004 as substantially equivalent to K021861 (Respironics, Inc., 2002) and 1 other predicate after a 17-day review. Its family tree reaches back 4 generations to 1996. 1 later device descends from it.
- Decided
- Sep 10, 2004
- Review
- 17 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K953930 (1996). 10 ancestors in all, the oldest K961783 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK953930 Virtuoso Smart Cpap SystemRespironics, Inc. · 1996
- 3 generations backK993433 Virtuoso LX Smart Cpap SystemRespironics, Inc. · 1999
- 2 generations backK012554 Remstar Auto Cpap SystemRespironics, Inc. · 2002
- 1 generation backK021861 Remstar Pro with C-Flex Cpap SystemRespironics, Inc. · 2002 · Recalled
- This deviceK042294 Slumbergear (TM), Model Multiple (004, 005, 005, 007)Suiter Enterprises, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK100343 Pap-CapPur-Sleep, Inc. · 2010
Most influential descendants
Showing 1 of 1 · See all- K100343Pap-CapPur-Sleep, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K953930 | Virtuoso Smart Cpap System | Respironics, Inc. | 1996 | — |
| −3 | K993433 | Virtuoso LX Smart Cpap System | Respironics, Inc. | 1999 | — |
| −2 | K012554 | Remstar Auto Cpap System | Respironics, Inc. | 2002 | — |
| −1 | K021861 | Remstar Pro with C-Flex Cpap System | Respironics, Inc. | 2002 | 1 |
| 0 (this device) | K042294 | Slumbergear (TM), Model Multiple (004, 005, 005, 007) | Suiter Enterprises, Inc. | 2004 | — |
| +1 | K100343 | Pap-Cap | Pur-Sleep, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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 |
|---|---|---|---|
| * | K021861 | Remstar Pro with C-Flex Cpap SystemSummary page 1…to a non-continuous ventilator/mask Classification Name: (pet 21 CFR Section 868.5905) Predicate Devices: REMstar Pro with C-Flex CPAP System K02 1861 Mirage VistaTm Mask K03 1047 Reason for Submission: New Device Device Description:… | 2002 |
| * | K031047 | Mirage Vista MaskSummary page 1…(pet 21 CFR Section 868.5905) Predicate Devices: REMstar Pro with C-Flex CPAP System K02 1861 Mirage VistaTm Mask K03 1047 Reason for Submission: New Device Device Description: SLUMBERGEARTm is a one-piece headgear with an integrated chi… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100343 | Pap-Cap | 2010 | 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 8 years and passes through 2 companies; a new generation was cleared every 2.3 years on median.
- 4 of the 10 ancestors have a recall of any class.
- Of its descendants, K100343 (Pur-Sleep, Inc., 2010) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K021861.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
SLUMBERGEARTM headgear is an accessory to a non-continuous ventilator
(respirator), intended for adult patients prescribed continuous positive airway
pressure (CPAP) and bi-level therapy in hospital, clinic, and/or home
environments. The headgear is reusable and for single-patient use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042294 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042294: Slumbergear (TM), Model Multiple (004, 005, 005, 007).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042294
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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