Cleared Traditional

K950447 - FILTER/HCH PRODUCT NUMBER 5710HEPA, 5710FILT

K950447 is an FDA 510(k) clearance for FILTER/HCH PRODUCT NUMBER 5710HEPA, manufactured by Vital Signs, Inc.. The device is a Class 1 Anesthesiology device with product code BYD cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K950447 · Vital Signs, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1995
Decision
18d
Days
Class 1
Risk

K950447 is an FDA 510(k) clearance for the FILTER/HCH PRODUCT NUMBER 5710HEPA, 5710FILT. Classified as Condenser, Heat And Moisture (artificial Nose) (product code BYD), Class I - General Controls.

Submitted by Vital Signs, Inc. (Totowa, US). The FDA issued a Cleared decision on February 21, 1995 after a review of 18 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 Vital Signs, Inc. devices

FDA 510(k) Submission Details - K950447

510(k) Number K950447 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1995
Decision Date February 21, 1995
Days to Decision 18 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
122d faster than avg
Panel avg: 140d · This submission: 18d
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 33
Devices cleared under the same product code (BYD) and FDA review panel - the closest regulatory comparables to K950447.
FHB, FHB-T WITH OR WITHOUT FLEXTUBE HFH, HFH-T, AFA, AFH-T WITH OR WITHOUT FLEXRTUBE
K952823 · Icor AB · Jul 1995
DISPODABLE HEAT & MOISTURE EXCHANGER AND FILTER/HME
K946209 · Med-Plastics Intl., Inc. · Jun 1995
FLEXLIFE
K952036 · Mallinckrodt Medical · Jun 1995
HEAT AND MOISTURE EXCHANGER FILTER (HME)
K943915 · Medicomp, Inc. · Oct 1994
HYGROLIFE
K942794 · Mallinckrodt Medical · Aug 1994
HEAT AND MOISTURE EXCHANGERS AND FILTERS
K941987 · Icor AB · Aug 1994