Cleared Traditional

K032910 - CARRIAZO PENDULAR

K032910 is an FDA 510(k) clearance for CARRIAZO PENDULAR, manufactured by Schwind Eye-Tech-Solutions GmbH & Co. KG. The device is a Class 1 Ophthalmic device with product code HNO cleared through the Traditional 510(k) pathway after a 343-day FDA review.

K032910 · Schwind Eye-Tech-Solutions GmbH & Co. KG · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2004
Decision
343d
Days
Class 1
Risk

K032910 is an FDA 510(k) clearance for the CARRIAZO PENDULAR. Classified as Keratome, Ac-powered (product code HNO), Class I - General Controls.

Submitted by Schwind Eye-Tech-Solutions GmbH & Co. KG (Coto De Caza, US). The FDA issued a Cleared decision on August 30, 2004 after a review of 343 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4370 - 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K032910

510(k) Number K032910 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2003
Decision Date August 30, 2004
Days to Decision 343 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
233d slower than avg
Panel avg: 110d · This submission: 343d
Pathway characteristics
Predicate-based equivalence.

HNO Device Classification - Class 1, General Controls

Product Code HNO Keratome, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4370
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 - HNO Keratome, Ac-powered

All 82
Devices cleared under the same product code (HNO) and FDA review panel - the closest regulatory comparables to K032910.
CENTURION SES EPIKERATOME
K042810 · Norwood Abbey , Ltd. · Oct 2004
MB 105 MILLENNIUM BLADES
K041110 · Millennium Biomedical, Inc. · Oct 2004
EPITOME SYSTEM
K041206 · Gebauer Medizintechnik GmbH · Sep 2004
M3 MICROKERATOME
K032836 · Moria SA · Jun 2004
M2 COMPATIBLE MICROKERATOME BLADE
K033457 · Micro Specialties, Inc. · May 2004
PRIZM KERATOME BLADE, MODEL MK8512M2
K033236 · Surgin Surgical Instrumentation, Inc. · Mar 2004
K032910 · CARRIAZO PENDULAR
Download PDF FDA Summary Schwind Eye-Tech-Solu…