Cleared Traditional

K851009 - INFUSION SLEEVE - OPHTHALMIC

K851009 is an FDA 510(k) clearance for INFUSION SLEEVE - OPHTHALMIC, manufactured by Medical Instrument Development Laboratories, Inc.. The device is a Class 2 Ophthalmic device with product code HQC cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K851009 · Medical Instrument Development Laboratories, Inc. · Ophthalmic device
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Apr 1985
Decision
22d
Days
Class 2
Risk

K851009 is an FDA 510(k) clearance for the INFUSION SLEEVE - OPHTHALMIC. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Medical Instrument Development Laboratories, Inc. (San Leandro, US). The FDA issued a Cleared decision on April 3, 1985 after a review of 22 days - a notably fast clearance cycle.

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: 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 Medical Instrument Development Laboratories, Inc. devices

FDA 510(k) Submission Details - K851009

510(k) Number K851009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1985
Decision Date April 03, 1985
Days to Decision 22 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
88d faster than avg
Panel avg: 110d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQC Device Classification - Class 2, Special Controls

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 135
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K851009.
KCP PAK CONVENIENCE PACK
K850148 · CooperVision, Inc. · Apr 1985
KCP (KELMAN COMPACT PHACO-EMULSIFIER) PEA
K850149 · CooperVision, Inc. · Apr 1985
KCP PAK #2 CONVENIENCE PACK MODIFICATION
K850275 · CooperVision, Inc. · Apr 1985
I/A BAC STOP KIT
K850899 · Staar Surgical Co. · Mar 1985
PHACO-BAC STOP KIT
K850900 · Staar Surgical Co. · Mar 1985
VISITEC OPHTHALMIC FLUID DISTRIB- SET
K843487 · Visitec Co. · Mar 1985