Cleared Traditional

K761338 - LEFF STETHOSCOPE FOR FETAL HEART

K761338 is an FDA 510(k) clearance for LEFF STETHOSCOPE FOR FETAL HEART, manufactured by J. Sklar Mfg. Co., Inc.. The device is a Class 1 Obstetrics & Gynecology device with product code HGN cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K761338 · J. Sklar Mfg. Co., Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1977
Decision
16d
Days
Class 1
Risk

K761338 is an FDA 510(k) clearance for the LEFF STETHOSCOPE FOR FETAL HEART. Classified as Stethoscope, Fetal (product code HGN), Class I - General Controls.

Submitted by J. Sklar Mfg. Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on January 12, 1977 after a review of 16 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 J. Sklar Mfg. Co., Inc. devices

FDA 510(k) Submission Details - K761338

510(k) Number K761338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1976
Decision Date January 12, 1977
Days to Decision 16 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
144d faster than avg
Panel avg: 160d · This submission: 16d
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.