Cleared Traditional

K091240 - ALPHAMED SURGICAL SPEAR, MODEL 70-5000

K091240 is an FDA 510(k) clearance for ALPHAMED SURGICAL SPEAR, manufactured by Alphamed, Inc.. The device is a Class 2 Ophthalmic device with product code HOZ cleared through the Traditional 510(k) pathway after a 179-day FDA review.

K091240 · Alphamed, Inc. · Ophthalmic device
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Oct 2009
Decision
179d
Days
Class 2
Risk

K091240 is an FDA 510(k) clearance for the ALPHAMED SURGICAL SPEAR, MODEL 70-5000. Classified as Sponge, Ophthalmic (product code HOZ), Class II - Special Controls.

Submitted by Alphamed, Inc. (El Paso, US). The FDA issued a Cleared decision on October 23, 2009 after a review of 179 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4790 - 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 Alphamed, Inc. devices

FDA 510(k) Submission Details - K091240

510(k) Number K091240 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2009
Decision Date October 23, 2009
Days to Decision 179 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d slower than avg
Panel avg: 110d · This submission: 179d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HOZ Device Classification - Class 2, Special Controls

Product Code HOZ Sponge, Ophthalmic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4790
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 - HOZ Sponge, Ophthalmic

All 33
Devices cleared under the same product code (HOZ) and FDA review panel - the closest regulatory comparables to K091240.
SUNTOUCH EYE SPEAR
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ULTRACELL ABSORBENT STICK
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MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES
K011191 · Medtronic Xomed, Inc. · Jun 2001
M-PACT CORNEAL LIGHT SHIELD
K993883 · M-Pact Corp. · Dec 1999
DRAINAGE WICK
K990671 · Hurricane Medical · May 1999