Cleared Traditional

K871854 - IN-LINE OPHTHALMIC IRRIGATING SOLUTION FILTERS

K871854 is an FDA 510(k) clearance for IN-LINE OPHTHALMIC IRRIGATING SOLUTION ..., manufactured by CooperVision, Inc.. The device is a Class 2 Ophthalmic device with product code HQC cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K871854 · CooperVision, Inc. · Ophthalmic device
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Jul 1987
Decision
75d
Days
Class 2
Risk

K871854 is an FDA 510(k) clearance for the IN-LINE OPHTHALMIC IRRIGATING SOLUTION FILTERS. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by CooperVision, Inc. (Irvine, US). The FDA issued a Cleared decision on July 27, 1987 after a review of 75 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.

FDA 510(k) Submission Details - K871854

510(k) Number K871854 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1987
Decision Date July 27, 1987
Days to Decision 75 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
35d faster than avg
Panel avg: 110d · This submission: 75d
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 315
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K871854.
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K872362 · Frigitronics of Connecticut, Inc. · Jul 1987
SITE PHACOEMULSIFICATION SYSTEM/OPHTHALMIC USE
K871485 · Site Microsurgical Systems, Inc. · Jun 1987
CLASSIC 70 LENS
K871649 · Korea Asahi Optical Co., Ltd. · May 1987
K871854 · IN-LINE OPHTHALMIC IRRIGATING SOLUTION FILTERS
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