510(k) Report

FDA applicant

Accutron, Inc.

Phoenix, AZ5 decisions1997–20054 recalls

FDA records 5 decisions for Accutron, Inc. (Phoenix, AZ) from 1997 to 2005: 5 510(k) clearances. Most are in product codes CBN (Apparatus, Gas-Scavenging) and BSZ (Gas-Machine, Anesthesia). Its devices cite 3 predicates, 1 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 Accutron, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Accutron, Inc. since 2007.

Recalls per year

4in 2012

2012: 4, 4 Class I
2007high 4 (2012) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Accutron, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • CBNApparatus, Gas-Scavenging2decisions
  • BSZGas-Machine, Anesthesia2decisions
  • KHAMask, Scavenging1decision

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 1 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.

  • K052335Analgesia Gas Machine, Model Digital UltraAccutron, Inc. · 20052cite it
  • K033503RFS Vacuum Gauge Scavenging CircuitAccutron, Inc. · 20041cites it
  • K965239Pip Low Profile Scavenging System (260 and 261)/Universal Low Profile Scavenging System (260-U and 261-U)Accutron, Inc. · 19971cites it

What has FDA decided for it lately?

  • K052335Analgesia Gas Machine, Model Digital UltraAccutron, Inc. · 20054 Class I recalls
  • K033503RFS Vacuum Gauge Scavenging CircuitAccutron, Inc. · 2004
  • K992421Guardian Low Pressure Alarm Accessory, Model 34076Accutron, Inc. · 1999
  • K965239Pip Low Profile Scavenging System (260 and 261)/Universal Low Profile Scavenging System (260-U and 261-U)Accutron, Inc. · 1997
  • K970046Universal Low Profile Nasal Hoods (1250,1275,1350,1450,1475,1550)Accutron, Inc. · 1997

All 5 as Accutron, Inc. →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K052335Flow Meter, CM Assembly, Model #27025, Serial # 13686, 13690, 13712, 13793. Flowmeter…Apr 29, 2012Class I
  • K052335Newport Portable Package, Model #50000, Serial # 13591, 13592, 13604, 13606, 13614…Apr 29, 2012Class I
  • K052335Ultra PC% Cabinet Mount Package G, Model #36600, Serial # 13593, 13594, 13595, 13596…Apr 29, 2012Class I
  • K052335CM Flowmeter Pkg H, Model #36700, Serial # 13749 Product Usage: Conscious Sedation Unit…Apr 29, 2012Class I