ClearanceBrief
Company ยท US

Ventec Life Systems, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 2017 to 2017. Name variants (Inc, Corp, punctuation) are merged.

1510(k) clearances (0 in 12 months)
20recalls (17 in 12 months)
16recalls that name a 510(k)

Product codes

CodeDeviceRecords
CBKVentilator, Continuous, Facility Use17
ECXCylinder, Compressed Gas, And Valve3
NOUContinuous, Ventilator, Home Use1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Apr 7, 2017K162877VOCSN Unified Respiratory System
Ventec Life Systems, Inc.
CBK

Latest recalls

DateFirm and productCodeLinked 510(k)
Oct 20, 2026Ventec Life Systems, Inc.
V*Home, Model Number: PRT-01444-000, Package PN:PRT-01445-000. used for ventilatory support.
Open, Classified		 CBKNone listed
Oct 20, 2026Ventec Life Systems, Inc.
V+ Pro Emergency, Model Number: PRT-01201-000, Package PN:PRT-01173-000,PRT-01222-000. used for ventilatory support.
Open, Classified		 CBKK162877
Oct 20, 2026Ventec Life Systems, Inc.
VC(Japan) Model Number: PRT-01098-100, Package PN:PRT-01125-100. used for ventilatory support.
Open, Classified		 CBKK162877
Oct 20, 2026Ventec Life Systems, Inc.
VC Model Number: PRT-01098-000, Package PN:PRT-01125-000. used for ventilatory support.
Open, Classified		 CBKK162877
Oct 20, 2026Ventec Life Systems, Inc.
V+Pro Model Number: PRT-01185-000, Package PN:PRT-01198-000; Model Number: PRT-01185-001, Package PN: N/A; Model Number: PRT-01185-002, Package PN:N/A. used for ventilatory support.
Open, Classified		 CBKK162877
Oct 20, 2026Ventec Life Systems, Inc.
VCSN+Pro Model Number: PRT-01184-000, Package PN:PRT-01172-000. used for ventilatory support.
Open, Classified		 CBKK162877
Oct 20, 2026Ventec Life Systems, Inc.
VOCSN (Japan) Model Number: PRT-01100-100, Package PN:PRT-01126-100. used for ventilatory support.
Open, Classified		 CBKK162877
Oct 20, 2026Ventec Life Systems, Inc.
VOCSN Model Number: PRT-01100-000, Package PN:PRT-01126-000. used for ventilatory support.
Open, Classified		 CBKK162877
Oct 20, 2026Ventec Life Systems, Inc.
VC+Pro (Japan) Model Number: PRT-00900-100, Package PN:PRT-00973-100. used for ventilatory support.
Open, Classified		 CBKK162877
Oct 20, 2026Ventec Life Systems, Inc.
VC+Pro Model Number: PRT-00900-001, Package PN:PRT-00973-000. used for ventilatory support.
Open, Classified		 CBKK162877
Oct 20, 2026Ventec Life Systems, Inc.
VOCSN+Pro (Japan), Model Number: PRT-00490-100, Package PN:PRT-00853-100. used for ventilatory support.
Open, Classified		 CBKK162877
Oct 20, 2026Ventec Life Systems, Inc.
VOCSN+Pro, Model Number:PRT-00490-001, Package PN:PRT-00853-000. used for ventilatory support.
Open, Classified		 CBKK162877
Sep 18, 2026Ventec Life Systems, Inc.
REF: HF2POSTD HomeFill Oxygen System HomeFill cylinder D with CGA870 Compatible Post Valve
Open, Classified		 ECXNone listed
Sep 18, 2026Ventec Life Systems, Inc.
REF:HF2PC9 HomeFill Oxygen System, HomeFill Cylinder M9 with Integrated Conserver
Open, Classified		 ECXNone listed
Sep 18, 2026Ventec Life Systems, Inc.
HF2P0ST9 HomeFill Oxygen System HomeFill Cylinder M9 with CGA870 Compatible Post Valve
Open, Classified		 ECXNone listed
Jun 23, 2026Ventec Life Systems, Inc.
VOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001
Open, Classified		 CBKK162877
May 1, 2026Ventec Life Systems, Inc.
VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000
Open, Classified		 NOUK162877
Feb 26, 2025Ventec Life Systems, Inc.
VOCSN Multi-Function Ventilators: VOCSN+Pro (V+O+C+S+N+Pro, English), REF: PRT-00490-001; V+Pro (V+Pro, English), REF: PRT-01185-000, PRT-01185-002
Open, Classified		 CBKK162877
Feb 23, 2024Ventec Life Systems, Inc.
VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue) REF PRT-01013-000 with pouch REF PRT-00802-001). Used with the VOCSN Unified Respiratory System which provides continuous or intermi
Open, Classified		 CBKK162877
Jun 21, 2021Ventec Life Systems, Inc.
Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-001; V+O+C+S+N+Pro/Japan/PRT-00490-100; V+C+Pro/English/PRT-00900-001; V+C+Pro/Japan/
Open, Classified		 CBKK162877
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