Cleared Traditional

K813298 - CONPHAR DELEE HILLIS STETHOSCOPE

K813298 is an FDA 510(k) clearance for CONPHAR DELEE HILLIS STETHOSCOPE, manufactured by Conphar, Inc.. The device is a Class 1 Obstetrics & Gynecology device with product code HGN cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K813298 · Conphar, Inc. · Obstetrics & Gynecology device
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Dec 1981
Decision
15d
Days
Class 1
Risk

K813298 is an FDA 510(k) clearance for the CONPHAR DELEE HILLIS STETHOSCOPE. Classified as Stethoscope, Fetal (product code HGN), Class I - General Controls.

Submitted by Conphar, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 8, 1981 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.2900 - the FDA obstetrics and gynecology 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 Conphar, Inc. devices

FDA 510(k) Submission Details - K813298

510(k) Number K813298 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1981
Decision Date December 08, 1981
Days to Decision 15 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
145d faster than avg
Panel avg: 160d · This submission: 15d
Pathway characteristics
Predicate-based equivalence.

HGN Device Classification - Class 1, General Controls

Product Code HGN Stethoscope, Fetal
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 884.2900
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.