Cleared Traditional

K823242 - PROGRAMALITH PROGRAMMER

K823242 is an FDA 510(k) clearance for PROGRAMALITH PROGRAMMER, manufactured by Pacesetter Systems. The device is a Class 2 Obstetrics & Gynecology device with product code KNG cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K823242 · Pacesetter Systems · Obstetrics & Gynecology device
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Jan 1983
Decision
68d
Days
Class 2
Risk

K823242 is an FDA 510(k) clearance for the PROGRAMALITH PROGRAMMER. Classified as Monitor, Ultrasonic, Fetal (product code KNG), Class II - Special Controls.

Submitted by Pacesetter Systems (Mchenry, US). The FDA issued a Cleared decision on January 8, 1983 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.2660 - 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.

FDA 510(k) Submission Details - K823242

510(k) Number K823242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1982
Decision Date January 08, 1983
Days to Decision 68 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
93d faster than avg
Panel avg: 161d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNG Device Classification - Class 2, Special Controls

Product Code KNG Monitor, Ultrasonic, Fetal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2660
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 Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - KNG Monitor, Ultrasonic, Fetal

All 59
Devices cleared under the same product code (KNG) and FDA review panel - the closest regulatory comparables to K823242.
HUNTLEIGH DOPCORD, D140
K854267 · Huntleigh Technology, Inc. · Jul 1986
COMBISCOPE
K852655 · Instrument Technology, Inc. · Feb 1986
OBSTETRICAL DOPPLER
K841805 · Epcom Medical Systems, Inc. · Jun 1984
FETAL PULSE DETECTORS, F50/F60
K812868 · South Carolina Medical, Inc. · Nov 1981
DOPPLEX-PLB & PXB
K810115 · Huntleigh Technology, Inc. · Jul 1981
GRAVIDAPHONE
K802024 · Solar Electronics · Jan 1981
K823242 · PROGRAMALITH PROGRAMMER
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