510(k) Report

FDA applicant

Vortran Medical Technology 1, Inc.

Sacramento, CA28 decisions1984–20212 recalls

FDA records 28 decisions for Vortran Medical Technology 1, Inc. (Sacramento, CA) from 1984 to 2021: 28 510(k) clearances. Most are in product codes CAF (Nebulizer (Direct Patient Interface)) and BTL (Ventilator, Emergency, Powered (Resuscitator)). Its devices cite 16 predicates, 10 of them its own earlier devices. 2 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 Vortran Medical Technology 1, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2008: 12011: 12016: 12017: 12018: 12019: 12021: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

2in 2017

2017: 2
2007high 2 (2017) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Vortran Medical Technology 1, 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?

  • CAFNebulizer (Direct Patient Interface)12decisions
  • BTLVentilator, Emergency, Powered (Resuscitator)6decisions
  • CCQNebulizer, Medicinal, Non-Ventilatory (Atomizer)3decisions
  • NHJDevice, Positive Pressure Breathing, Intermittent3decisions
  • CAPMonitor, Airway Pressure (Includes Gauge And/Or Alarm)3decisions
  • BSKCuff, Tracheal Tube, Inflatable1decision

Whose devices does it build on?

Its devices cite 16 predicates; 10 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 16 times; 10 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.

  • K935693Autoneb Breath Actuated Controller and Accessory KitVortran Medical Technology 1, Inc. · 19945cite it
  • K001430Respirtech Pro-O2C, Model 2200 and Respirtech Pro, Model 2000Vortran Medical Technology 1, Inc. · 20003cite it
  • K041473Var-Plus (Vortran Automatic Resuscitator), Model PCMVortran Medical Technology 1, Inc. · 20043cite it
  • K973975RespirtechproVortran Medical Technology 1, Inc. · 19982cite it
  • K073261Var MonitorVortran Medical Technology 1, Inc. · 20081cites it
  • K943600UniheartVortran Medical Technology 1, Inc. · 19941cites it

What has FDA decided for it lately?

  • K202219VORTRAN GO2VENT with PEEP ValveVortran Medical Technology 1, Inc. · 2021
  • K182292VORTRAN APM-PlusVortran Medical Technology 1, Inc. · 2019
  • K173914VORTRAN Cuff Inflator (VCI)Vortran Medical Technology 1, Inc. · 2018
  • K162968Vortran GO2VENTVortran Medical Technology 1, Inc. · 2017
  • K153733VORTRAN ManometerVortran Medical Technology 1, Inc. · 2016
  • K103639Vortran Airway Pressure Monitor (Vapm)-Adult, Vortran Airway Pressure Monitor (Vapm)- PediatricVortran Medical Technology 1, Inc. · 2011
  • K073261Var MonitorVortran Medical Technology 1, Inc. · 2008
  • K041473Var-Plus (Vortran Automatic Resuscitator), Model PCMVortran Medical Technology 1, Inc. · 20042 recalls

All 28 as Vortran Medical Technology 1, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K001430VORTRAN Automatic Resuscitator, VARPlus; Model PTE-5002; Qty: 10 each Anesthesiology…Apr 20, 2017Class II
  • K001430VORTRAN Automatic Resuscitator, VARPlus with Extension Kit; Model PCE-5012; Qty: 10…Apr 20, 2017Class II