Cleared Traditional

K953619 - WARM N WET HME W/LUER ADAPTER

K953619 is an FDA 510(k) clearance for WARM N WET HME W/LUER ADAPTER, manufactured by Hospitak, Inc.. The device is a Class 1 Anesthesiology device with product code BYD cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K953619 · Hospitak, Inc. · Anesthesiology device
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Aug 1995
Decision
22d
Days
Class 1
Risk

K953619 is an FDA 510(k) clearance for the WARM N WET HME W/LUER ADAPTER. Classified as Condenser, Heat And Moisture (artificial Nose) (product code BYD), Class I - General Controls.

Submitted by Hospitak, Inc. (Farmingdale, US). The FDA issued a Cleared decision on August 25, 1995 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5375 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hospitak, Inc. devices

FDA 510(k) Submission Details - K953619

510(k) Number K953619 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1995
Decision Date August 25, 1995
Days to Decision 22 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 140d · This submission: 22d
Pathway characteristics
Predicate-based equivalence.

BYD Device Classification - Class 1, General Controls

Product Code BYD Condenser, Heat And Moisture (artificial Nose)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5375
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - BYD Condenser, Heat And Moisture (artificial Nose)

All 24
Devices cleared under the same product code (BYD) and FDA review panel - the closest regulatory comparables to K953619.
HEAT & MOISTURE EXCHANGER
K955008 · Intertech Resources, Inc. · Jan 1996
HEAT MOISTURE EXCHANGER
K953580 · Intertech Resources, Inc. · Sep 1995
WARM N WET HMEF W/LUER ADAPTER
K953620 · Hospitak, Inc. · Aug 1995
FLEXLIFE
K952036 · Mallinckrodt Medical · Jun 1995
FILTER/HCH PRODUCT NUMBER 5710HEPA, 5710FILT
K950447 · Vital Signs, Inc. · Feb 1995
HEAT AND MOISTURE EXCHANGER FILTER (HME)
K943915 · Medicomp, Inc. · Oct 1994