510(k) Report

FDA applicant

Precision Medical, Inc.

Northampton, PA30 decisions1984–20185 recalls

FDA records 30 decisions for Precision Medical, Inc. (Northampton, PA) from 1984 to 2018: 30 510(k) clearances. Most are in product codes CAX (Flowmeter, Tube, Thorpe, Back-Pressure…) and BTI (Compressor, Air, Portable). Its devices cite 10 predicates, 4 of them its own earlier devices. 5 recalls are linked to its devices.

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 Precision Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2007: 12008: 12009: 12011: 22014: 12018: 1
2007high 2 (2011) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2015

2010: 12015: 1
2007high 1 (2010) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Precision Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • CAXFlowmeter, Tube, Thorpe, Back-Pressure Compensated3decisions
  • BTICompressor, Air, Portable3decisions
  • BTAPump, Portable, Aspiration (Manual Or Powered)3decisions
  • CAWGenerator, Oxygen, Portable2decisions
  • CCLAnalyzer, Gas, Oxygen, Gaseous-Phase2decisions
  • CAFNebulizer (Direct Patient Interface)2decisions

Also: CAN (2), BXY (2), BYJ (2), NFB (2), BZR (2), KDP (2).

Whose devices does it build on?

Its devices cite 10 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 22 times; 4 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.

  • K053232Precision BlenderPrecision Medical, Inc. · 20066cite it
  • K971749Easygo AspiratorPrecision Medical, Inc. · 19983cite it
  • K140179Easy GO VacPrecision Medical, Inc. · 20143cite it
  • K041122Precision Liquid Oxygen SystemPrecision Medical, Inc. · 20043cite it
  • K090781HELIO2 BlenderPrecision Medical, Inc. · 20092cite it
  • K923324Precision Mist CompressorPrecision Medical, Inc. · 19931cites it

What has FDA decided for it lately?

  • K173807Accu O2 Oxygen AnalyzerPrecision Medical, Inc. · 2018
  • K140179Easy GO VacPrecision Medical, Inc. · 2014
  • K103563Precision Portable Oxygen Concentration Model 4150Precision Medical, Inc. · 2011
  • K103324Precision Liquid Oxygen SystemPrecision Medical, Inc. · 2011
  • K090781HELIO2 BlenderPrecision Medical, Inc. · 2009
  • K072348Precision Oxygen ConcentratorPrecision Medical, Inc. · 2008
  • K063096Precision Oxygen MonitorPrecision Medical, Inc. · 2007
  • K053232Precision BlenderPrecision Medical, Inc. · 2006

All 30 as Precision Medical, Inc. →

What has been recalled?

5 recalls linked to its devices; the latest:

  • K901831Easy Dial Oxygen Regulator, 168708D and 168715D. Eight liter from .0.25 to 8 liters, 15…Oct 8, 2015Class II
  • K843223PM1000 Flow Selector - An accessory to an emergency ventilator (resuscitator). The…Mar 5, 2010
  • K041122Precision Medical- Easy Mate Portable Liquid Oxygen System (container), PM22010 Series…Oct 4, 2006
  • K971749Easy Go Vac Aspirator, Model PM65. Portable suction unitNov 9, 2004
  • K971749Easy Go Vac Aspirator, Model PM65HG. Portable suction unitNov 9, 2004