510(k) · Cleared
ClearedBreas Isleep 20+
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Breas Medical AB · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Jun 23, 2006 as substantially equivalent to K030985 (Vital Signs, Inc., 2003) after a 67-day review. Its family tree reaches back 6 generations to 1990.
- Decided
- Jun 23, 2006
- Review
- 67 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K903764 (1990). 14 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK903764 Companion 318 Nasal Cpap SystemPuritan Bennett Corp. · 1990
- 5 generations backK960518 The Puritan-Bennett 318 Plus Nasal Cpap SystemPuritan Bennett Corp. · 1996
- 4 generations backK980365 Goodknight 418 Cpap SystemNellcor Puritan Bennett, Inc. · 1998
- 3 generations backK991150 Nellcor Puritan Bennett, Goodknight 418GNellcor Puritan Bennett France Dvpt. · 1999
- 2 generations backK993584 Mallinckrodt, Goodknight 418A, Goodknight 418P, Silverlining 2Nellcor Puritan Bennett France Dvpt. · 2000
- 1 generation backK030985 Breas PV 10I Cpap System, Model PV 10IVital Signs, Inc. · 2003
- This deviceK061057 Breas Isleep 20+Breas Medical AB · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K903764 | Companion 318 Nasal Cpap System | Puritan Bennett Corp. | 1990 | — |
| −5 | K960518 | The Puritan-Bennett 318 Plus Nasal Cpap System | Puritan Bennett Corp. | 1996 | — |
| −4 | K980365 | Goodknight 418 Cpap System | Nellcor Puritan Bennett, Inc. | 1998 | — |
| −3 | K991150 | Nellcor Puritan Bennett, Goodknight 418G | Nellcor Puritan Bennett France Dvpt. | 1999 | — |
| −2 | K993584 | Mallinckrodt, Goodknight 418A, Goodknight 418P, Silverlining 2 | Nellcor Puritan Bennett France Dvpt. | 2000 | — |
| −1 | K030985 | Breas PV 10I Cpap System, Model PV 10I | Vital Signs, Inc. | 2003 | — |
| 0 (this device) | K061057 | Breas Isleep 20+ | Breas Medical AB | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 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? (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 | Decided |
|---|---|---|---|
| * | K030985 | Breas PV 10I Cpap System, Model PV 10ISummary page 1…m Classification Name Non-continuous ventilator (21 CFR 868.5905) Product Code BZD Predicate Device Breas PVIOi (K030985) Page 3.1 510(k) Premarket N… | 2003 |
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 16 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- None of the 14 ancestors has a recall.
- 2 other devices also cite its predicate K030985.
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?
The Breas iSleep 20+ System is intended to deliver Continuous Positive Airway Pressure (CPAP) therapy for the treatment of adult Obstructive Sleep Apnea (OSA).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061057 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061057: Breas Isleep 20+.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061057
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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