Cleared Traditional

K871440 - KRATZ NOVA-SERT

K871440 is an FDA 510(k) clearance for KRATZ NOVA-SERT, manufactured by CooperVision, Inc.. The device is a Class 1 Ophthalmic device with product code KYB cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K871440 · CooperVision, Inc. · Ophthalmic device
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May 1987
Decision
24d
Days
Class 1
Risk

K871440 is an FDA 510(k) clearance for the KRATZ NOVA-SERT. Classified as Lens, Guide, Intraocular (product code KYB), Class I - General Controls.

Submitted by CooperVision, Inc. (Bellevue, US). The FDA issued a Cleared decision on May 7, 1987 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4300 - 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

FDA 510(k) Submission Details - K871440

510(k) Number K871440 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1987
Decision Date May 07, 1987
Days to Decision 24 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
86d faster than avg
Panel avg: 110d · This submission: 24d
Pathway characteristics
Predicate-based equivalence.

KYB Device Classification - Class 1, General Controls

Product Code KYB Lens, Guide, Intraocular
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4300
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KYB Lens, Guide, Intraocular

All 19
Devices cleared under the same product code (KYB) and FDA review panel - the closest regulatory comparables to K871440.
AMO PHACOFLEX II INTERSECTION SYSTEM
K961242 · Allergan, Inc. · Jun 1996
MICROSTAAR INJECTOR MODELS MSI-TD & MSI-PD (MODIFICATION)
K954600 · Staar Surgical Co. · Dec 1995
PASSPORT FOLDABLE LENS PLACEMENT SYSTEM
K951292 · Chiron Vision Corp. · Jun 1995
KRATZ NOVA-SERT. SOFT INTRAOCULAR LENS INJECTOR
K870265 · CooperVision, Inc. · Feb 1987
SOFT LENS FOLDER
K861990 · Staar Surgical Co. · Jun 1986
ELASTIC LENS INJECTOR TM
K861085 · Staar Surgical Co. · May 1986