Cleared Traditional

K853475 - GRAM-MA NEONATAL SC

K853475 is an FDA 510(k) clearance for GRAM-MA NEONATAL SC, manufactured by Kentec Medical, Inc.. The device is a Class 1 General Hospital device with product code FRW cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K853475 · Kentec Medical, Inc. · General Hospital
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Sep 1985
Decision
16d
Days
Class 1
Risk

K853475 is an FDA 510(k) clearance for the GRAM-MA NEONATAL SC. Classified as Scale, Patient (product code FRW), Class I - General Controls.

Submitted by Kentec Medical, Inc. (Irvine, US). The FDA issued a Cleared decision on September 5, 1985 after a review of 16 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2720 - the FDA general hospital 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 Kentec Medical, Inc. devices

FDA 510(k) Submission Details - K853475

510(k) Number K853475 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1985
Decision Date September 05, 1985
Days to Decision 16 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 129d · This submission: 16d
Pathway characteristics
Predicate-based equivalence.

FRW Device Classification - Class 1, General Controls

Product Code FRW Scale, Patient
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.2720
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 - FRW Scale, Patient

All 15
Devices cleared under the same product code (FRW) and FDA review panel - the closest regulatory comparables to K853475.
OLYMPIC SMART SCALE
K871104 · Olympic Medical Corp. · May 1987
WARM WEIGH MODEL N-10 INFANT SCALE
K870888 · Air-Shields, Inc. · Mar 1987
MODEL 304-S EXTERNAL MICRO-VOLUME INFUSION PUMP
K864327 · Medtronic Minimed · Feb 1987
MODEL AS* 6C INFUSION PUMP
K791566 · Baxter Healthcare Corp · Nov 1979
WEIGHING STATION, MOBILE PATIENT
K760545 · Gaymar Industries, Inc. · Nov 1976