Cleared Traditional

K992553 - IQ CHAMBERS

K992553 is an FDA 510(k) clearance for IQ CHAMBERS, manufactured by Dormer Laboratories, Inc.. The device is a Class 1 General Hospital device with product code KXF cleared through the Traditional 510(k) pathway after a 257-day FDA review.

K992553 · Dormer Laboratories, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2000
Decision
257d
Days
Class 1
Risk

K992553 is an FDA 510(k) clearance for the IQ CHAMBERS. Classified as Applicator, Absorbent Tipped, Non-sterile (product code KXF), Class I - General Controls.

Submitted by Dormer Laboratories, Inc. (Washington, US). The FDA issued a Cleared decision on April 12, 2000 after a review of 257 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6025 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Dormer Laboratories, Inc. devices

FDA 510(k) Submission Details - K992553

510(k) Number K992553 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1999
Decision Date April 12, 2000
Days to Decision 257 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
128d slower than avg
Panel avg: 129d · This submission: 257d
Pathway characteristics
Predicate-based equivalence.

KXF Device Classification - Class 1, General Controls

Product Code KXF Applicator, Absorbent Tipped, Non-sterile
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6025
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 - KXF Applicator, Absorbent Tipped, Non-sterile

All 12
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