Cleared Traditional

K810227 - MODEL #53110 DISPOSABLE ANOSCOPE

K810227 is the FDA 510(k) clearance for MODEL #53110 DISPOSABLE ANOSCOPE by Welch Allyn, Inc.. It is a Class 2 Chemistry device (product code FER) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K810227 · Welch Allyn, Inc. · Chemistry device
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Feb 1981
Decision
23d
Days
Class 2
Risk

K810227 is an FDA 510(k) clearance for the MODEL #53110 DISPOSABLE ANOSCOPE. Classified as Anoscope And Accessories (product code FER), Class II - Special Controls.

Submitted by Welch Allyn, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 19, 1981 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 876.1500 - the FDA in vitro diagnostics and chemistry 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 Welch Allyn, Inc. devices

Submission Details

510(k) Number K810227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1981
Decision Date February 19, 1981
Days to Decision 23 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 88d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FER Anoscope And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Examine And Perform Procedures Within The Anus And Rectum.
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 Chemistry devices follow this clearance model.