510(k) · Cleared

Cleared

Breas Isleep 20I

K063476510(k) SpecialCleared Jan 22, 200767-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

Breas Medical AB · BZD Ventilator, Non-Continuous (Respirator)

Cleared on Jan 22, 2007 as substantially equivalent to K030985 (Vital Signs, Inc., 2003) after a 67-day review. Its family tree reaches back 6 generations to 1990. 12 later devices descend from it.

Decided: Jan 22, 2007
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. 12 later devices descend from it, 2 citing it directly.

By dateBy generation

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 deviceK063476 Breas Isleep 20IBreas Medical AB · 2007
Descendant · cites it directly · 10 of its ownK071560 Provent Nasal Dilator, Model BR2Ventus Medical, Inc. · 2008
Descendant · 2 generations on · 5 of its ownK111549 Attune Sleep Apnea SystemApnicure, Inc. · 2012
Descendant · 3 generations on · 3 of its ownK122130 Winx Sleep Therapy SystemApnicure, Inc. · 2012
Descendant · 2 generations on · 3 of its ownK090398 Provent Professional Sleep Apnea TherapyVentus Medical, Inc. · 2009 · Recalled
Descendant · 3 generations on · 2 of its ownK130538 Winx Sleep Therapy SystemApnicure, Inc. · 2013

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2008high 2 (2012) · low 0 (2011)2026

Most influential descendants

Showing 5 of 12 · See all

K071560Provent Nasal Dilator, Model BR2Ventus Medical, Inc. · 2008 · cites it directly10descendants
K111549Attune Sleep Apnea SystemApnicure, Inc. · 2012 · 2 generations on5descendants
K122130Winx Sleep Therapy SystemApnicure, Inc. · 2012 · 3 generations on3descendants
K090398Provent Professional Sleep Apnea TherapyVentus Medical, Inc. · 2009 · 2 generations on3descendants
K130538Winx Sleep Therapy SystemApnicure, Inc. · 2013 · 3 generations on2descendants

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)	K063476	Breas Isleep 20I	Breas Medical AB	2007	—
+1	K071560	Provent Nasal Dilator, Model BR2	Ventus Medical, Inc.	2008	—
+2	K111549	Attune Sleep Apnea System	Apnicure, Inc.	2012	—
+3	K122130	Winx Sleep Therapy System	Apnicure, Inc.	2012	—
+2	K090398	Provent Professional Sleep Apnea Therapy	Ventus Medical, Inc.	2009	1
+3	K130538	Winx Sleep Therapy System	Apnicure, Inc.	2013	—

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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2009	1	0
2010	1	0
2012	2	0
2013	1	0
2014	2	0
2018	1	0
2020	2	0
2023	1	0

FIG. 1 — Lineage of K063476, 1990–2023Source: 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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K030985	Breas PV 10I Cpap System, Model PV 10I Summary page 1 …em Classification Name Non-continuous ventilator (21 CFR 868.5905) Product Code BZD Predicate Device Breas PVI 01 (K030985) Page 3.1 51O(kW Premarket No…	Vital Signs, Inc.	2003	—

Also cleared against K030985: 2 other devices →

What descends from it? (12)

See all 12

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K071560	Provent Nasal Dilator, Model BR2	Ventus Medical, Inc.	2008	10
K140929	Z1 Cpap System	Human Design Medical, LLC	2014	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 17 years and passes through 5 companies; a new generation was cleared every 3.3 years on median.
None of the 14 ancestors has a recall.
Of its descendants, K071560 (Ventus Medical, Inc., 2008) has gone furthest, with 10 descendants of its own.
2 other devices also cite its predicate K030985.

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 Breas iSleep 20i 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/K063476 · printed Nov 6, 2026

Cite this page

510(k) Report. “K063476: Breas Isleep 20I.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063476

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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