Cleared Traditional

OCULAB BIOMETRICPEN (K860061) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K860061 · Oculab, Inc. · Radiology device
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Mar 1986
Decision
63d
Days
Class 2
Risk

K860061 is an FDA 510(k) clearance for the OCULAB BIOMETRICPEN. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Oculab, Inc. (Glendale, US). The FDA issued a Cleared decision on March 10, 1986 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - the FDA radiology and imaging software oversight 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 Oculab, Inc. devices

Submission Details

510(k) Number K860061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1986
Decision Date March 10, 1986
Days to Decision 63 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 107d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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 Radiology devices follow this clearance model.

Regulatory Peers - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 212
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K860061.
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SONOLINE CD
K852686 · Siemens Medical Solutions USA, Inc. · Mar 1986
2.5 MHZ PHASED ARRAY SECTOR MERIDIAN PROBE
K854743 · Johnson & Johnson Professionals, Inc. · Feb 1986
ULTRASOUND COUPLANT SHEET/SOLID ULTRASOUND COUPLAN
K853702 · Johnson & Johnson Professionals, Inc. · Feb 1986
SONOLINE LX
K853946 · Siemens Medical Solutions USA, Inc. · Jan 1986