Cleared Traditional

K905365 - INSTRUMENT MAKAR GRAVITY ASSIST SYSTEM

K905365 is an FDA 510(k) clearance for INSTRUMENT MAKAR GRAVITY ASSIST SYSTEM, manufactured by Instrument Makar, Inc.. The device is a Class 1 General Hospital device with product code KYZ cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K905365 · Instrument Makar, Inc. · General Hospital
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Feb 1991
Decision
77d
Days
Class 1
Risk

K905365 is an FDA 510(k) clearance for the INSTRUMENT MAKAR GRAVITY ASSIST SYSTEM. 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 February 6, 1991 after a review of 77 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

FDA 510(k) Submission Details - K905365

510(k) Number K905365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1990
Decision Date February 06, 1991
Days to Decision 77 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 129d · This submission: 77d
Pathway characteristics
Predicate-based equivalence.

KYZ Device Classification - Class 1, General Controls

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 14
Devices cleared under the same product code (KYZ) and FDA review panel - the closest regulatory comparables to K905365.
SURGICAL SEALANT APPLICATOR TIP ENDOSCOPIC TIP
K940371 · Micromedics, Inc. · Apr 1994
WELCH ALLYN EARCLEANER
K931946 · Welch Allyn, Inc. · Jul 1993
IRRIGATION TRAY W/ BULB SYRINGE
K924809 · Customed, Inc. · Jun 1993
GRAVITY ASSIST
K902854 · Instrument Makar, Inc. · Aug 1990
IRRIGATION TRAY
K896800 · Westmark, Sterile Packing Systems, Inc. (Sps) · May 1990
STRYKER TRAUMA TRAY
K894470 · Stryker Corp. · Aug 1989