Cleared Traditional

K813607 - ACKRAD N-DO VAGE TUBE

K813607 is an FDA 510(k) clearance for ACKRAD N-DO VAGE TUBE, manufactured by Ackrad Laboratories. The device is a Class 2 General Hospital device with product code FQH cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K813607 · Ackrad Laboratories · General Hospital
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Feb 1982
Decision
38d
Days
Class 2
Risk

K813607 is an FDA 510(k) clearance for the ACKRAD N-DO VAGE TUBE. Classified as Lavage, Jet (product code FQH), Class II - Special Controls.

Submitted by Ackrad Laboratories (Mchenry, US). The FDA issued a Cleared decision on February 5, 1982 after a review of 38 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5475 - 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 Ackrad Laboratories devices

FDA 510(k) Submission Details - K813607

510(k) Number K813607 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1981
Decision Date February 05, 1982
Days to Decision 38 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
91d faster than avg
Panel avg: 129d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FQH Device Classification - Class 2, Special Controls

Product Code FQH Lavage, Jet
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5475
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 General Hospital devices follow this clearance model.

Regulatory Peers - FQH Lavage, Jet

All 33
Devices cleared under the same product code (FQH) and FDA review panel - the closest regulatory comparables to K813607.
EXCEL PULSED IRRIGATION/SUCTION SYSTEM
K873466 · Stryker Corp. · Nov 1987
DAVOL SURGICAL SUCTION IRRIGATION INSTR
K830386 · C.R. Bard, Inc. · Mar 1983
MICRO-AIRE DISPOSABLE MINI & MAXI LAVAG
K820661 · Micro-Aire Surgical Instruments, Inc. · Apr 1982
XOMED MICRO-IRRIGATOR
K813475 · Xomed, Inc. · Feb 1982
EXETER BONE LAUAGE SYSTEM
K790811 · Howmedica Corp. · Jul 1979