510(k) Report

510(k) · Cleared

Cleared

Breas PV 10I Cpap System, Model PV 10I

K030985510(k) TraditionalCleared Oct 15, 2003201-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

Vital Signs, Inc. · BZD Ventilator, Non-Continuous (Respirator)

Cleared on Oct 15, 2003 as substantially equivalent to K001553 (Vital Signs, Inc., 2000) and 5 other predicates after a 201-day review. Its family tree reaches back 5 generations to 1990. 20 later devices descend from it.

Decided
Oct 15, 2003
Review
201 days
Class
Class II
Product code
BZD
Recalls
None
Predicates
6

Its longest line of descent runs back 5 generations to K903764 (1990). 13 ancestors in all. 20 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor1999: 1 other ancestor1998: 1 other ancestor1997: 2 other ancestors1996: 1 other ancestor1995: 1 other ancestor1994: 1 other ancestor2005: 1 descendant cleared2007: 1 descendant cleared2006: 1 descendant cleared2010: 2 descendants cleared2014: 2 descendants cleared2008: 1 descendant cleared2012: 2 descendants cleared2009: 1 descendant cleared2013: 3 descendants cleared2015: 1 descendant cleared2018: 2 descendants cleared2020: 2 descendants cleared2023: 1 descendant clearedK903764 · Companion 318 Nasal Cpap System · Puritan Bennett Corp. · 1990K960518 · The Puritan-Bennett 318 Plus Nasal Cpap System · Puritan Bennett Corp. · 1996K980365 · Goodknight 418 Cpap System · Nellcor Puritan Bennett, Inc. · 1998K991150 · Nellcor Puritan Bennett, Goodknight 418G · Nellcor Puritan Bennett France Dvpt. · 1999K993584 · Mallinckrodt, Goodknight 418A, Goodknight 418P, Silverlining 2 · Nellcor Puritan Bennett France Dvpt. · 20001990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors5 generations back: 3 other ancestors 1 generation forward: 3 descendants2 generations forward: 3 descendants3 generations forward: 6 descendants4 generations forward: 6 descendants5 generations forward: 1 descendant6 generations forward: 1 descendant K993584 · Mallinckrodt, Goodknight 418A, Goodknight 418P, Silverlining 2 · Nellcor Puritan Bennett France Dvpt. · 2000K991150 · Nellcor Puritan Bennett, Goodknight 418G · Nellcor Puritan Bennett France Dvpt. · 1999K980365 · Goodknight 418 Cpap System · Nellcor Puritan Bennett, Inc. · 1998K960518 · The Puritan-Bennett 318 Plus Nasal Cpap System · Puritan Bennett Corp. · 1996K903764 · Companion 318 Nasal Cpap System · Puritan Bennett Corp. · 1990−50+5
  1. Root · 5 generations backK903764 Companion 318 Nasal Cpap SystemPuritan Bennett Corp. · 1990
  2. 4 generations backK960518 The Puritan-Bennett 318 Plus Nasal Cpap SystemPuritan Bennett Corp. · 1996
  3. 3 generations backK980365 Goodknight 418 Cpap SystemNellcor Puritan Bennett, Inc. · 1998
  4. 2 generations backK991150 Nellcor Puritan Bennett, Goodknight 418GNellcor Puritan Bennett France Dvpt. · 1999
  5. 1 generation backK993584 Mallinckrodt, Goodknight 418A, Goodknight 418P, Silverlining 2Nellcor Puritan Bennett France Dvpt. · 2000
  6. This deviceK030985 Breas PV 10I Cpap System, Model PV 10IVital Signs, Inc. · 2003
  7. Descendant · cites it directly · 12 of its ownK063476 Breas Isleep 20IBreas Medical AB · 2007
  8. Descendant · 2 generations on · 10 of its ownK071560 Provent Nasal Dilator, Model BR2Ventus Medical, Inc. · 2008
  9. Descendant · cites it directly · 6 of its ownK042945 Aura Cpap SystemAeiomed, Inc. · 2005
  10. Descendant · 3 generations on · 5 of its ownK111549 Attune Sleep Apnea SystemApnicure, Inc. · 2012
  11. Descendant · 2 generations on · 5 of its ownK100121 Model 300157 Cpap SystemAeiomed, Inc. · 2010

Showing 5 of 20 descendants. See all descendants

Descendants cleared per year

2005: 12006: 12007: 12008: 12009: 12010: 22012: 22013: 32014: 22015: 12018: 22020: 22023: 1
2005high 3 (2013) · low 0 (2011)2026

Most influential descendants

Showing 5 of 20 · See all
  • K063476Breas Isleep 20IBreas Medical AB · 2007 · cites it directly12descendants
  • K071560Provent Nasal Dilator, Model BR2Ventus Medical, Inc. · 2008 · 2 generations on10descendants
  • K042945Aura Cpap SystemAeiomed, Inc. · 2005 · cites it directly6descendants
  • K111549Attune Sleep Apnea SystemApnicure, Inc. · 2012 · 3 generations on5descendants
  • K100121Model 300157 Cpap SystemAeiomed, Inc. · 2010 · 2 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K903764Companion 318 Nasal Cpap SystemPuritan Bennett Corp.1990—
−4K960518The Puritan-Bennett 318 Plus Nasal Cpap SystemPuritan Bennett Corp.1996—
−3K980365Goodknight 418 Cpap SystemNellcor Puritan Bennett, Inc.1998—
−2K991150Nellcor Puritan Bennett, Goodknight 418GNellcor Puritan Bennett France Dvpt.1999—
−1K993584Mallinckrodt, Goodknight 418A, Goodknight 418P, Silverlining 2Nellcor Puritan Bennett France Dvpt.2000—
0 (this device)K030985Breas PV 10I Cpap System, Model PV 10IVital Signs, Inc.2003—
+1K063476Breas Isleep 20IBreas Medical AB2007—
+2K071560Provent Nasal Dilator, Model BR2Ventus Medical, Inc.2008—
+1K042945Aura Cpap SystemAeiomed, Inc.2005—
+3K111549Attune Sleep Apnea SystemApnicure, Inc.2012—
+2K100121Model 300157 Cpap SystemAeiomed, Inc.2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199510
199610
199720
199810
199910
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200610
200710
200810
200910
201020
201220
201330
201420
201510
201820
202020
202310
FIG. 1 — Lineage of K030985, 1990–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K250624 myAirscore 15.7 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (6)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K001553Breas PV 100 Cpap SystemVital Signs, Inc.2000—
*K970516Sullivan Autoset Home Nasal Cpap System
Summary page 1
…ZD Predicate Devices: Breas PVlOO CPAP System (KOO1553) ResMed Sullivan Autoset@T (K9705 16, K970771, and K984428) Page 1 51…
Resmed, Ltd.1997—
*K970771Sullivan Autoset Portable II Nasal Cpap System
Summary page 1
…icate Devices: Breas PVlOO CPAP System (KOO1553) ResMed Sullivan Autoset@T (K9705 16, K970771, and K984428) Page 1 51W)Premark…
Resmed, Ltd.1997—
*K984428Sullivan Autoset Nasal Cpap System
Summary page 1
…: Breas PVlOO CPAP System (KOO1553) ResMed Sullivan Autoset@T (K9705 16, K970771, and K984428) Page 1 51W)Premarket Notificati…
Resmed, Ltd.1999—
*K980721Sullivan Autoset
Summary page 5
…use, with follow-up after three and six months. The self-adjusting CPAP devices included in this study were the Breas PVlOi, the ResMed AutoSet@T (K980721), the Mallinckrodt Goodbight@ 41 8P (K993584), and the Weinmann SomnoSmart@. Conclusions were based on apn…
Resmed, Ltd.1998—
*K993584Mallinckrodt, Goodknight 418A, Goodknight 418P, Silverlining 2
Summary page 5
…hs. The self-adjusting CPAP devices included in this study were the Breas PVlOi, the ResMed AutoSet@T (K980721), the Mallinckrodt Goodbight@ 41 8P (K993584), and the Weinmann SomnoSmart@. Conclusions were based on apnea-hypopnea indices (AHI), Epworth sleepiness…
Nellcor Puritan Bennett France Dvpt.2000—

What descends from it? (20)

See all 20

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

NumberDeviceApplicantDecidedDescendants
K063476Breas Isleep 20IBreas Medical AB200712
K042945Aura Cpap SystemAeiomed, Inc.20056
K061057Breas Isleep 20+Breas Medical AB20060

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 13 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
  • None of the 13 ancestors has a recall.
  • Of its descendants, K063476 (Breas Medical AB, 2007) has gone furthest, with 12 descendants of its own.

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.

FDA decisions per year · BZD

7in 2025

2007: 212008: 172009: 232010: 122011: 232012: 212013: 232014: 142015: 112016: 122017: 52018: 52019: 62020: 62021: 62022: 42023: 52024: 102025: 72026 (partial year): 10
2007high 23 (2009) · low 4 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BZD

189in 2025

2007: 83 days median2008: 108 days median2009: 90 days median2010: 122 days median2011: 125 days median2012: 133 days median2013: 127 days median2014: 172 days median2015: 224 days median2016: 217 days median2017: 221 days median2018: 280 days median2019: 231 days median2020: 137 days median2021: 192 days median2022: 253 days median2023: 204 days median2024: 132 days median2025: 189 days median2026 (partial year): 214 days median
2007high 280 (2018) · low 83 (2007)2026

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

Recalls per year · BZD

8in 2023

2007: 292008: 22009: 12011: 12019: 4, 4 Class I2023: 8, 7 Class I2026 (partial year): 2, 2 Class I
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

2007: 652008: 672009: 1472010: 1432011: 1892012: 1392013: 822014: 862015: 1142016: 1182017: 1482018: 1012019: 1882020: 1262021: 6,0662022: 90,7682023: 27,9872024: 68,2622025: 60,279
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200721832965
200817108267
200923901147
2010121220143
2011231251189
2012211330139
201323127082
201414172086
2015112240114
2016122170118
201752210148
201852800101
201962314 (4)188
202061370126
2021619206,066
20224253090,768
202352048 (7)27,987
202410132068,262
20257189060,279
2026102142 (2)—

What is it indicated for?

The Breas PV 1Oi CPAP 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.

More from Vital Signs, Inc.

75 FDA decisions under this applicant name. See the company

  • K112902Enflow IV Fluid WarmerVital Signs, Inc. · 2012
  • K041309Imask TMVital Signs, Inc. · 2004
  • K022402Disposable Pressure ManometerVital Signs, Inc. · 2002
  • K021315Sure-LokVital Signs, Inc. · 2002
  • K002454Breas HA50 Humidifier, Model HA50Vital Signs, Inc. · 2001

Recent decisions in BZD

The BZD category page

  • K260251BreathCare PAP III (YH-390N)Suzhou Yuyue Medical Technology Co., Ltd. · 2026
  • K261262Altis Full Face MaskRespironics, Inc. · 2026
  • K253044RXiBreeze PAP System (RXiBreeze 20C)Resvent Medical Technology Co., Ltd. · 2026
  • K253553OrionResmed Corp · 2026
  • K254104ResScan EssentialsResmed Corp · 2026

https://510kreport.com/device/K030985 · printed Nov 3, 2026

Cite this page

510(k) Report. “K030985: Breas PV 10I Cpap System, Model PV 10I.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K030985

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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