510(k) Report

FDA applicant

A Plus Medical

Carlsbad, CA7 decisions2009–20124 recalls

FDA records 7 decisions for A Plus Medical (Carlsbad, CA) from 2009 to 2012: 7 510(k) clearances. Most are in product codes BZD (Ventilator, Non-Continuous (Respirator)) and NHK (Resuscitator, Manual, Non Self-Inflating). Its devices cite 11 predicates, 3 of them its own earlier devices. 4 recalls are linked to its devices, 4 Class I.

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

FIG. A — Illustration, anesthesiology panel, where it files most

How often FDA has decided A Plus Medical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2009: 22010: 22011: 22012: 1
2009high 2 (2009) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

4in 2019

2019: 4, 4 Class I
2009high 4 (2019) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — A Plus Medical by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • BZDVentilator, Non-Continuous (Respirator)3decisions
  • NHKResuscitator, Manual, Non Self-Inflating1decision
  • CAPMonitor, Airway Pressure (Includes Gauge And/Or Alarm)1decision
  • BTMVentilator, Emergency, Manual (Resuscitator)1decision
  • BYEAttachment, Breathing, Positive End Expiratory Pressure1decision

Whose devices does it build on?

Its devices cite 11 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 3 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K093716Babi Plus Infant Nasal Cannula SystemA Plus Medical · 20102cite it
  • K092687Venti.Plus Hyperinflation Bag System with Pressure ManometerA Plus Medical · 20091cites it
  • K110471Babi Plus Infant Nasal Cannula SystemA Plus Medical · 20111cites it
  • K090317Babi*Plus Bubble Pap ValveA Plus Medical · 20091cites it

What has FDA decided for it lately?

  • K112852Babi Plus Neonatal Resuscitation BagA Plus Medical · 2012
  • K110471Babi Plus Infant Nasal Cannula SystemA Plus Medical · 2011
  • K110383Babi*Plus Pressure Relief Manifold - 10CM H20, 12.5CM H20, 15CM H20A Plus Medical · 20114 Class I recalls
  • 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
  • K090317Babi*Plus Bubble Pap ValveA Plus Medical · 2009

All 7 as A Plus Medical →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K110383Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.Jun 14, 2019Class I
  • K110383Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only…May 30, 2019Class I
  • K110383Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562May 30, 2019Class I
  • K110383Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor…May 30, 2019Class I