510(k) Report

FDA applicant

Pulmonetic Systems, Inc.

Plymouth, MN12 decisions1998–200917 recalls

FDA records 12 decisions for Pulmonetic Systems, Inc. (Plymouth, MN) from 1998 to 2009: 12 510(k) clearances. All are in product code CBK (Ventilator, Continuous, Facility Use). Its devices cite 18 predicates, 7 of them its own earlier devices. 17 recalls are linked to its devices, 2 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 Pulmonetic Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2007: 12009: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2014

2008: 82010: 22011: 12012: 1, 1 Class I2014: 1, 1 Class I
2007high 8 (2008) · low 0 (2007)2026

Class I Class II/III not classified

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

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

See the 510(k) Report

Which product codes does it file in?

  • CBKVentilator, Continuous, Facility Use12decisions

Whose devices does it build on?

Its devices cite 18 predicates; 7 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 45 times; 7 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.

  • K060647LTV 1200 VentilatorPulmonetic Systems, Inc. · 20069cite it
  • K984056LTV 1000Pulmonetic Systems, Inc. · 19997cite it
  • K051767LTV 1000 VentilatorPulmonetic Systems, Inc. · 20056cite it
  • K981371LTV 1000 VentilatorPulmonetic Systems, Inc. · 19986cite it
  • K032226LTV-1000 VentilatorPulmonetic Systems, Inc. · 20034cite it
  • K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc. · 20073cite it

What has FDA decided for it lately?

  • K083688Pulmonetic Systems LTV 1200 MR Conditional VentilatorPulmonetic Systems, Inc. · 20091 recall
  • K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc. · 20072 Class I recalls
  • K060647LTV 1200 VentilatorPulmonetic Systems, Inc. · 2006
  • K060549Automobile Lighter Power CordPulmonetic Systems, Inc. · 2006
  • K051767LTV 1000 VentilatorPulmonetic Systems, Inc. · 2005
  • K040790Modification to LTV 1000 Ventilator/Breathing CircuitsPulmonetic Systems, Inc. · 2004
  • K040540Modification to LTV 1000 VentilatorPulmonetic Systems, Inc. · 20048 recalls
  • K032226LTV-1000 VentilatorPulmonetic Systems, Inc. · 20031 recall

All 12 as Pulmonetic Systems, Inc. →

What has been recalled?

17 recalls linked to its devices; the latest:

  • K070594CareFusion EnVe and ReVel Ventilators. The EnVe/ ReVel Ventilator is designed for use on…Aug 8, 2014Class I
  • K070594CareFusion EnVe Ventilator Designed for use on patients who require respiratory support…Jun 19, 2012Class I
  • K070594CareFusion EnVe Ventilator, Model 19250-001. Manufactured by: CareFusion, 22745 Savi…Sep 12, 2011
  • K083688Pulmonetic Systems P/N 19189-001 Patient Circuit SPU W/O PEEP 15 FT 5/Pkg. These…Jul 2, 2010
  • K070594Cardinal Health EnVe Ventilator Cat # 19250-001, Manufactured by Cardinal Health…Jan 8, 2010
  • K002881Viasys Healthcare, Pulmonetic Systems LTV 1000 Ventilator The ventilator is suitable for…Feb 22, 2008