Cleared Traditional

K850149 - KCP (KELMAN COMPACT PHACO-EMULSIFIER) PEA

K850149 is the FDA 510(k) clearance for KCP (KELMAN COMPACT PHACO-EMULSIFIER) PEA by CooperVision, Inc.. It is a Class 2 Ophthalmic device (product code HQC) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K850149 · CooperVision, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1985
Decision
91d
Days
Class 2
Risk

K850149 is an FDA 510(k) clearance for the KCP (KELMAN COMPACT PHACO-EMULSIFIER) PEA. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by CooperVision, Inc. (Irvine, US). The FDA issued a Cleared decision on April 15, 1985 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4670 - the FDA ophthalmic 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 Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all CooperVision, Inc. devices

Submission Details

510(k) Number K850149 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1985
Decision Date April 15, 1985
Days to Decision 91 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 110d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HQC Unit, Phacofragmentation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4670
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 Ophthalmic devices follow this clearance model.

Regulatory Peers - HQC Unit, Phacofragmentation

All 80
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K850149.
COOPERVISION ACAP POWER DRIVE ULTRASONIC ANTERIOR
K854375 · CooperVision, Inc. · Dec 1985
COOPER VISION SYSTEM VI U/S MODULE
K853070 · CooperVision, Inc. · Aug 1985
KCP PAK CONVENIENCE PACK
K850148 · CooperVision, Inc. · Apr 1985
KCP PAK #2 CONVENIENCE PACK MODIFICATION
K850275 · CooperVision, Inc. · Apr 1985
VISITEC OPHTHALMIC FLUID DISTRIB- SET
K843487 · Visitec Co. · Mar 1985
COOPERVISION SYSTEM VI
K842945 · CooperVision, Inc. · Dec 1984