Cleared Traditional

K983783 - HEATED HUMIDIFIER

K983783 is an FDA 510(k) clearance for HEATED HUMIDIFIER, manufactured by Pegasus Research Corp.. The device is a Class 2 Anesthesiology device with product code BTT cleared through the Traditional 510(k) pathway after a 728-day FDA review.

K983783 · Pegasus Research Corp. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2000
Decision
728d
Days
Class 2
Risk

K983783 is an FDA 510(k) clearance for the HEATED HUMIDIFIER. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Pegasus Research Corp. (Santa Ana, US). The FDA issued a Cleared decision on October 24, 2000 after a review of 728 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5450 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

FDA 510(k) Submission Details - K983783

510(k) Number K983783 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1998
Decision Date October 24, 2000
Days to Decision 728 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
588d slower than avg
Panel avg: 140d · This submission: 728d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTT Device Classification - Class 2, Special Controls

Product Code BTT Humidifier, Respiratory Gas, (direct Patient Interface)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5450
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 - BTT Humidifier, Respiratory Gas, (direct Patient Interface)

All 179
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K983783.
SMOOTH-FLO CIRCUIT
K010402 · Hudson Respiratory Care, Inc. · Mar 2001
BREAS HA50 HUMIDIFIER, MODEL HA50
K002454 · Vital Signs, Inc. · Mar 2001
CONCHATHERM 2000 HUMIDIFICATION SYSTEM, MODELS 500-00, -10, -20, -30, -40, -50, & -60
K001213 · Hudson Respiratory Care, Inc. · Nov 2000
IPI HUMIDIFIER CHAMBER
K993282 · I.P.I. Medical Products · Sep 2000
HUMID-HEAT
K993773 · Hudson Rcj AB · Sep 2000
VAPOTHERM, MODEL 2000I
K000401 · Vapotherm, Inc. · Aug 2000