Cleared Traditional

K902854 - GRAVITY ASSIST

K902854 is the FDA 510(k) clearance for GRAVITY ASSIST by Instrument Makar, Inc.. It is a Class 1 General Hospital device (product code KYZ) cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K902854 · Instrument Makar, Inc. · General Hospital
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Aug 1990
Decision
61d
Days
Class 1
Risk

K902854 is an FDA 510(k) clearance for the GRAVITY ASSIST. Classified as Syringe, Irrigating (non Dental) (product code KYZ), Class I - General Controls.

Submitted by Instrument Makar, Inc. (Okemos, US). The FDA issued a Cleared decision on August 29, 1990 after a review of 61 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6960 - 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 Instrument Makar, Inc. devices

Submission Details

510(k) Number K902854 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 1990
Decision Date August 29, 1990
Days to Decision 61 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
68d faster than avg
Panel avg: 129d · This submission: 61d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KYZ Syringe, Irrigating (non Dental)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6960
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 - KYZ Syringe, Irrigating (non Dental)

All 8
Devices cleared under the same product code (KYZ) and FDA review panel - the closest regulatory comparables to K902854.
RMI DUAL FLUID IRRIGATING SYRINGE
K964833 · Research Medical, Inc. · Feb 1997
WELCH ALLYN EARCLEANER
K931946 · Welch Allyn, Inc. · Jul 1993
IRRIGATION TRAY W/ BULB SYRINGE
K924809 · Customed, Inc. · Jun 1993
STRYKER TRAUMA TRAY
K894470 · Stryker Corp. · Aug 1989
CLEAN-FLUSH
K830572 · Burron Medical Products, Inc. · Mar 1983
IRRIJET
K810209 · Ackrad Laboratories · Feb 1981