Cleared Traditional

LTV 1000 (K984056) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K984056 · Pulmonetic Systems, Inc. · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Apr 1999
Decision
150d
Days
Class 2
Risk

K984056 is an FDA 510(k) clearance for the LTV 1000. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Pulmonetic Systems, Inc. (Colton, US). The FDA issued a Cleared decision on April 12, 1999 after a review of 150 days - an extended review cycle.

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 Pulmonetic Systems, Inc. devices

Submission Details

510(k) Number K984056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1998
Decision Date April 12, 1999
Days to Decision 150 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 140d · This submission: 150d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CBK Ventilator, Continuous, 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 - CBK Ventilator, Continuous, Facility Use

All 107
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K984056.
PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTION
K001646 · Puritan Bennett Corp. · Oct 2000
ESPIRT
K001208 · Respironics, Inc. · May 2000
PURITAN-BENNETT VENTILATOR SYSTEM WITH ET/TRACHEOSTOMY TUBE COMPENSATION, TC, OPTION, MODEL 840
K993071 · Puritan Bennett Corp. · Nov 1999
PURITAN-BENNETT 840 VENTILATORY SYSTEM WITH BILEVEL OPTION
K984535 · Puritan Bennett Corp. · Dec 1998
NELLCOR PURITAN BENNETT, 760 VENTILATOR SYSTEM
K984379 · Puritan Bennett Corp. · Dec 1998
ESPRIT VENTILATOR
K981072 · Respironics, Inc. · Nov 1998