Cleared Traditional

K871871 - SERIES TEN THOUSAND OCUTOME

K871871 is the FDA 510(k) clearance for SERIES TEN THOUSAND OCUTOME by CooperVision, Inc.. It is a Class 2 Ophthalmic device (product code HQE) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K871871 · CooperVision, Inc. · Ophthalmic device
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Jun 1987
Decision
29d
Days
Class 2
Risk

K871871 is an FDA 510(k) clearance for the SERIES TEN THOUSAND OCUTOME. Classified as Instrument, Vitreous Aspiration And Cutting, Ac-powered (product code HQE), Class II - Special Controls.

Submitted by CooperVision, Inc. (Irvine, US). The FDA issued a Cleared decision on June 11, 1987 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4150 - 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 CooperVision, Inc. devices

Submission Details

510(k) Number K871871 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1987
Decision Date June 11, 1987
Days to Decision 29 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
81d faster than avg
Panel avg: 110d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HQE Instrument, Vitreous Aspiration And Cutting, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4150
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 - HQE Instrument, Vitreous Aspiration And Cutting, Ac-powered

All 36
Devices cleared under the same product code (HQE) and FDA review panel - the closest regulatory comparables to K871871.
DREYER CURVED ENDOILLUMINATOR
K884556 · Advanced Surgical Products, Inc. · Feb 1989
NIDEK CV-4000
K880929 · Nidek, Inc. · May 1988
PRISMA TECH 19 GAUGE DISPOSABLE EXTRUSION NEEDLES
K881927 · Advanced Surgical Products, Inc. · May 1988
SERIES TEN THOUSAND MASTER
K861380 · CooperVision, Inc. · Jul 1986
SERIES TEN THOUSAND COMPACT
K861565 · CooperVision, Inc. · Jul 1986
STORZ DAISY
K854508 · Storz Instrument Co. · Feb 1986