Cleared Traditional

K961036 - MBI FIBEROPTIC ENDO-ILLUMINATOR

K961036 is an FDA 510(k) clearance for MBI FIBEROPTIC ENDO-ILLUMINATOR, manufactured by M.B. Industries, Inc.. The device is a Class 2 Ophthalmic device with product code MPA cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K961036 · M.B. Industries, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 1996
Decision
123d
Days
Class 2
Risk

K961036 is an FDA 510(k) clearance for the MBI FIBEROPTIC ENDO-ILLUMINATOR. Classified as Endoilluminator (product code MPA), Class II - Special Controls.

Submitted by M.B. Industries, Inc. (Granite City, US). The FDA issued a Cleared decision on July 15, 1996 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 876.1500 - 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.

FDA 510(k) Submission Details - K961036

510(k) Number K961036 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1996
Decision Date July 15, 1996
Days to Decision 123 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
13d slower than avg
Panel avg: 110d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MPA Device Classification - Class 2, Special Controls

Product Code MPA Endoilluminator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
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 - MPA Endoilluminator

All 40
Devices cleared under the same product code (MPA) and FDA review panel - the closest regulatory comparables to K961036.
SYNTEC, INC. DISPOSABLE BARE END FIBER
K971338 · Syntec, Inc. · May 1997
VITROTEC TRUE LIGHT ENDOILLUMINATOR (100-S)
K964555 · Vitrotec, Inc. · Mar 1997
VITLITE (TR7700)
K963417 · Escalon Trek Medical · Dec 1996
STORZ MVS 1011A DISPOSABLE FIBEROPTIC ENDOILLUMINATOR
K960007 · Storz · Mar 1996
GAMP & ASSOCIATES DISPOSABLE FIBEROPTIC VISCOINJECTOR
K952581 · Gamp & Assoc. · Jan 1996
GAMP & ASSOCIATES DISPOSABLE END IRRIGATING ENDOILLUMINATOR
K952585 · Gamp & Assoc. · Jan 1996
K961036 · MBI FIBEROPTIC ENDO-ILLUMINATOR
Download PDF FDA Summary M.B. Industries, Inc.