510(k) Report

510(k) · Cleared

Recalled · Class I · 2019

Babi*Plus Pressure Relief Manifold - 10CM H20, 12.5CM H20, 15CM H20

K110383510(k) TraditionalCleared Aug 1, 2011172-day reviewClass II21 CFR 868.5905Recalls 4 (4 Class I)

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

A Plus Medical · BZD Ventilator, Non-Continuous (Respirator)

Cleared on Aug 1, 2011 as substantially equivalent to K093716 (A Plus Medical, 2010) and 1 other predicate after a 172-day review. Its family tree reaches back 2 generations to 1983. 1 of the 5 devices in its family, counting itself, has a Class I recall. It has been recalled 4 times, including 4 Class I recalls.

Decided
Aug 1, 2011
Review
172 days
Class
Class II
Product code
BZD
Recalls
4 (4 Class I)
Predicates
2

Its longest line of descent runs back 2 generations to K831246 (1983). 4 ancestors in all. No later device cites it as a predicate yet. 1 of the 5 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year cleared 2010: 1 other ancestor1987: 1 other ancestorK831246 · Whistler in-Line Pressure Release Valve · Airlife, Inc. · 1983K040366 · Pressure Manifold, Model BC 110 · Fisher & Paykel Healthcare, Ltd. · 20041980198519901995200020052010
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor K040366 · Pressure Manifold, Model BC 110 · Fisher & Paykel Healthcare, Ltd. · 2004K831246 · Whistler in-Line Pressure Release Valve · Airlife, Inc. · 19830
  1. Root · 2 generations backK831246 Whistler in-Line Pressure Release ValveAirlife, Inc. · 1983
  2. 1 generation backK040366 Pressure Manifold, Model BC 110Fisher & Paykel Healthcare, Ltd. · 2004
  3. This deviceK110383 Babi*Plus Pressure Relief Manifold - 10CM H20, 12.5CM H20, 15CM H20A Plus Medical · 2011
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K831246Whistler in-Line Pressure Release ValveAirlife, Inc.1983—
−1K040366Pressure Manifold, Model BC 110Fisher & Paykel Healthcare, Ltd.2004—
0 (this device)K110383Babi*Plus Pressure Relief Manifold - 10CM H20, 12.5CM H20, 15CM H20A Plus Medical2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
201010
FIG. 1 — Lineage of K110383, 1983–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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.

1 device in this family has a Class I recall. 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K093716Babi Plus Infant Nasal Cannula System
Summary page 1
…nuous (respirator) Product Code: EZO Regulation: 868.5905 Device Class: 11 Device: UoblAPus Pressure Limitation Manifold Predicate Devices: K Number: K093716 Product Name: Infant Nasal Cannula System Manufacturer: A Plus Medical Product Codes: 20216 & 20217 K Number:…
A Plus Medical2010—
*K040366Pressure Manifold, Model BC 110
Summary page 1
…vices: K Number: K093716 Product Name: Infant Nasal Cannula System Manufacturer: A Plus Medical Product Codes: 20216 & 20217 K Number: K040366 Product Name: BC I 10 Pressure Manifold Manufacturer: Fisher & Paykel Healthcare Product Codes: BC I 10 & RC…
Fisher & Paykel Healthcare, Ltd.2004—

Also cleared against K093716: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (1 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jun 14, 2019Class IZ-0009-2020Device DesignDevice vented gas below the stated pressure.
May 30, 2019Class IZ-0021-2020Device DesignReports of pressure relief manifold venting gas below the standard pressure.
May 30, 2019Class IZ-0020-2020Device DesignReports of pressure relief manifold venting gas below the standard pressure.
May 30, 2019Class IZ-0022-2020Device DesignReports of pressure relief manifold venting gas below the standard pressure.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 28 years and passes through 3 companies; a new generation was cleared every 20.6 years on median.
  • 1 of the 4 ancestors has a recall of any class.
  • 1 other device also cites its predicate K093716.

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. 2011, this device’s year, is highlighted.

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?

Single patient use device intended for neonate, infant or child with a body mass of less than 10 Kg requiring a pressure limitation system to eliminate excessive pressure should an obstruction occur between gas supply and exhalation port during continuous gas flow therapy up to 12 liters per minute in hospital critical care unit.

Indications for use as stated in the FDA summary.

Also cleared against K093716

1 other device cites the same predicate.

  • K110471Babi Plus Infant Nasal Cannula SystemA Plus Medical · 2011

More from A Plus Medical

7 FDA decisions under this applicant name. See the company

  • K112852Babi Plus Neonatal Resuscitation BagA Plus Medical · 2012
  • K110471Babi Plus Infant Nasal Cannula SystemA Plus Medical · 2011
  • K102377Ventiplus Disposable Manometer 0-60 CM H2O; Ventiplus Disposable Manometer 0-20 CM H2O; Ventiplus Disposable…A Plus Medical · 2010
  • K093716Babi Plus Infant Nasal Cannula SystemA Plus Medical · 2010
  • K092687Venti.Plus Hyperinflation Bag System with Pressure ManometerA Plus Medical · 2009

Recent decisions in BZD

The BZD category page

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  • 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/K110383 · printed Nov 6, 2026

Cite this page

510(k) Report. “K110383: Babi*Plus Pressure Relief Manifold - 10CM H20, 12.5CM H20, 15CM H20.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110383

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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