Cleared Traditional

K864810 - LIDSPLINT

K864810 is the FDA 510(k) clearance for LIDSPLINT by Precision Therapeutics, Inc.. It is a Class 1 General & Plastic Surgery device (product code HMP) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K864810 · Precision Therapeutics, Inc. · General & Plastic Surgery device
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Jan 1987
Decision
42d
Days
Class 1
Risk

K864810 is an FDA 510(k) clearance for the LIDSPLINT. Classified as Pad, Eye (product code HMP), Class I - General Controls.

Submitted by Precision Therapeutics, Inc. (Las Vegas, US). The FDA issued a Cleared decision on January 20, 1987 after a review of 42 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4440 - the FDA general and plastic surgery 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 Precision Therapeutics, Inc. devices

Submission Details

510(k) Number K864810 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1986
Decision Date January 20, 1987
Days to Decision 42 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 115d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HMP Pad, Eye
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4440
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 - HMP Pad, Eye

Devices cleared under the same product code (HMP) and FDA review panel - the closest regulatory comparables to K864810.
STERILE,DISPOSABLE EYE DRESSING
K921349 · Deroyal Industries, Inc. · May 1992
DONALDSON NATURAL EYEPATCH 'PATIENT PAK'
K874411 · Keeler Instruments, Inc. · Jan 1988
DONALDSON NATURAL EYEPATCH
K860979 · Keeler Instruments, Inc. · Apr 1986
VISITEC EYE SHIELD
K843197 · Visitec Co. · Oct 1984
CONPHAR EYE PROTECTOR
K803145 · Conphar, Inc. · Feb 1981