510(k) Report

FDA applicant

Ventlab Corp.

Mocksville, NC23 decisions1989–201822 recalls

FDA records 23 decisions for Ventlab Corp. (Mocksville, NC) from 1989 to 2018: 23 510(k) clearances. Most are in product codes BTM (Ventilator, Emergency, Manual (Resuscitator)) and CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase). Its devices cite 1 predicate, 0 of them its own earlier devices. 22 recalls are linked to its devices, 12 Class I.

FDA’s records also spell it “Ventlab, LLC”.

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 Ventlab Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2008: 22009: 22011: 22012: 12018: 1
2007high 2 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

9in 2023

2012: 11, 11 Class I2014: 1, 1 Class I2016: 12023: 9
2007high 11 (2012) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Ventlab Corp.’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?

  • BTMVentilator, Emergency, Manual (Resuscitator)2decisions
  • CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase2decisions
  • CAFNebulizer (Direct Patient Interface)2decisions
  • NHKResuscitator, Manual, Non Self-Inflating2decisions
  • BZOSet, Tubing And Support, Ventilator (W Harness)2decisions
  • BSJMask, Gas, Anesthetic1decision

Also: CBH (1), CAH (1), CAN (1), CAP (1), BTR (1), BTT (1).

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K012842V*Care Manual ResuscitatorVentlab Corp. · 20011cites it

What has FDA decided for it lately?

  • K173373SafeT T-Piece ResuscitatorVentlab, LLC · 2018
  • K120118Ventlab Pressurechek Disosable Column ManometerVentlab Corp. · 2012
  • K102674Cuff SentryVentlab Corp. · 2011
  • K093617Ventlab 6000 Series HumidifierVentlab Corp. · 2011
  • K093525Ace/Statcheck II CO2 Indicator, Ace/Statcheck II CO2 Indicator Arm Assemby Adult Statcheck Resuscitator with…Ventlab Corp. · 20091 recall
  • K090840Ventlab 5000 Series Nebulizer Assembly, Cup, Cup W/ Mask, Cup W/ Fitsall Conn.Ventlab Corp. · 2009
  • K082204Series SY Disposable Electrosurgical PadVentlab Corp. · 2008
  • K063813Ventlab Nasal CO2 Sampling/O2 Delivery CannulaVentlab Corp. · 2008

All 22 as Ventlab Corp. →The one decision as Ventlab, LLC →

What has been recalled?

22 recalls linked to its devices; the latest:

  • K012842Ventlab, LLC SafeSpot manual resuscitators with integrated manometer, multiple accessory…Oct 11, 2023Class II
  • K012842Medline manual resuscitators with integrated manometer, multiple accessory…Oct 11, 2023Class II
  • K012842Ventlab, LLC AirFlow manual resuscitator devices with integrated manometer, multiple…Oct 11, 2023Class II
  • K012842Ventlab, LLC STAT-Check manual resuscitators with integrated manometer, multiple…Oct 11, 2023Class II
  • K012842Ventlab, LLC RescuMed manual resuscitators with integrated manometer, multiple accessory…Oct 11, 2023Class II
  • K012842Ventlab, LLC BreathTech manual resuscitators with integrated manometer, multiple…Oct 11, 2023Class II