Cleared Traditional

K830572 - CLEAN-FLUSH

K830572 is an FDA 510(k) clearance for CLEAN-FLUSH, manufactured by Burron Medical Products, Inc.. The device is a Class 1 General Hospital device with product code KYZ cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K830572 · Burron Medical Products, Inc. · General Hospital
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Mar 1983
Decision
22d
Days
Class 1
Risk

K830572 is an FDA 510(k) clearance for the CLEAN-FLUSH. Classified as Syringe, Irrigating (non Dental) (product code KYZ), Class I - General Controls.

Submitted by Burron Medical Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 17, 1983 after a review of 22 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 Burron Medical Products, Inc. devices

FDA 510(k) Submission Details - K830572

510(k) Number K830572 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1983
Decision Date March 17, 1983
Days to Decision 22 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
107d faster than avg
Panel avg: 129d · This submission: 22d
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 19
Devices cleared under the same product code (KYZ) and FDA review panel - the closest regulatory comparables to K830572.
STERILE IRRIGATION TRAYS
K890728 · Cypress Medical Products, Ltd. · Jun 1989
SURGICAL SEALANT APPLICATOR
K883338 · Micromedics, Inc. · Aug 1988
SURGICAL SEALANT DISPENSER (SSD)
K881020 · Micromedics, Inc. · Mar 1988
IRRIJET
K810209 · Ackrad Laboratories · Feb 1981
IRRIGATION CAP
K780794 · Travenol Laboratories, S.A. · Jul 1978