Cleared Traditional

K982454 - BIPAP VISION VENTILATORY SUPPORT

K982454 is an FDA 510(k) clearance for BIPAP VISION VENTILATORY SUPPORT, manufactured by Respironics, Inc.. The device is a Class 2 Anesthesiology device with product code MNT cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K982454 · Respironics, Inc. · Anesthesiology device
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Nov 1998
Decision
111d
Days
Class 2
Risk

K982454 is an FDA 510(k) clearance for the BIPAP VISION VENTILATORY SUPPORT. Classified as Ventilator, Continuous, Minimal Ventilatory Support, Facility Use (product code MNT), Class II - Special Controls.

Submitted by Respironics, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on November 3, 1998 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Respironics, Inc. devices

FDA 510(k) Submission Details - K982454

510(k) Number K982454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received July 15, 1998
Decision Date November 03, 1998
Days to Decision 111 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 140d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNT Device Classification - Class 2, Special Controls

Product Code MNT Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - MNT Ventilator, Continuous, Minimal Ventilatory Support, Facility Use

All 15
Devices cleared under the same product code (MNT) and FDA review panel - the closest regulatory comparables to K982454.
V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS
K102985 · Respironics, Inc. · Apr 2011
ACUTE CARE FACE MASK, MODEL RT040
K060044 · Fisher &Paykel Healthcare , Ltd. · Apr 2006
STICK-ON DISPOSABLE NASAL MASK, MODEL 312174, 1001964
K990574 · Respironics, Inc. · May 1999
SULLIVAN VPAP II ST VENTILATORY SUPPORT SYSTEM
K974539 · Resmed, Ltd. · Aug 1998
KNIGHTSTAR 335
K973004 · Puritan Bennett Corp. · Jul 1998
BIPAP S/T-D 30 SYSTEM
K955324 · Respironics, Inc. · Dec 1996