Cleared Traditional

K875003 - PRISMA DISPOSABLE PUPIL CENTERING CANNULA

K875003 is an FDA 510(k) clearance for PRISMA DISPOSABLE PUPIL CENTERING CANNULA, manufactured by Advanced Surgical Products, Inc.. The device is a Class 1 Ophthalmic device with product code HMX cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K875003 · Advanced Surgical Products, Inc. · Ophthalmic device
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Apr 1988
Decision
131d
Days
Class 1
Risk

K875003 is an FDA 510(k) clearance for the PRISMA DISPOSABLE PUPIL CENTERING CANNULA. Classified as Cannula, Ophthalmic (product code HMX), Class I - General Controls.

Submitted by Advanced Surgical Products, Inc. (Chesterfield, US). The FDA issued a Cleared decision on April 13, 1988 after a review of 131 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4350 - 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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Advanced Surgical Products, Inc. devices

FDA 510(k) Submission Details - K875003

510(k) Number K875003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1987
Decision Date April 13, 1988
Days to Decision 131 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
21d slower than avg
Panel avg: 110d · This submission: 131d
Pathway characteristics
Predicate-based equivalence.

HMX Device Classification - Class 1, General Controls

Product Code HMX Cannula, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4350
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 - HMX Cannula, Ophthalmic

All 48
Devices cleared under the same product code (HMX) and FDA review panel - the closest regulatory comparables to K875003.
PRISMA DISPOSABLE U-SHAPED CANNULA
K874998 · Advanced Surgical Products, Inc. · Apr 1988
PRISMA DISPOSABLE ATKINSON RETROBULBAR NEEDLE
K874999 · Advanced Surgical Products, Inc. · Apr 1988
PRISMA DISPOSABLE VISCOELASTIC I/A CANNULA
K875002 · Advanced Surgical Products, Inc. · Apr 1988
DISPOSABLE INFUSION CANNULA 0045-1/2/3 2.5/4.0/6.0
K873853 · Advanced Surgical Products, Inc. · Mar 1988
LOOK IRRIGATING/ASPIRATING CANNULA W/TEFLON SHEATH
K872884 · Look, Inc. · Aug 1987
MVS 2.5MM, 4.0MM, 6.0MM INFUSION CANNULA
K871605 · Advanced Surgical Products, Inc. · Jun 1987