Cleared Traditional

K840495 - MANUAL IRRIGATING/ASPIRATING UNIT

K840495 is the FDA 510(k) clearance for MANUAL IRRIGATING/ASPIRATING UNIT by Alltek, Inc.. It is a Class 2 Ophthalmic device (product code HQC) cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K840495 · Alltek, Inc. · Ophthalmic device
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Jun 1984
Decision
134d
Days
Class 2
Risk

K840495 is an FDA 510(k) clearance for the MANUAL IRRIGATING/ASPIRATING UNIT. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Alltek, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 19, 1984 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4670 - 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 Alltek, Inc. devices

Submission Details

510(k) Number K840495 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1984
Decision Date June 19, 1984
Days to Decision 134 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 110d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HQC Unit, Phacofragmentation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4670
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 - HQC Unit, Phacofragmentation

All 99
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K840495.
IOCARE ULTRASONIC TITANIUM TIPS
K843278 · Chiron Vision Corp. · Nov 1984
MENDEZ U/S CYSTOTOME
K843386 · CooperVision, Inc. · Nov 1984
SITE SIMCOE STYLE I/A HANDPIECE
K842458 · Chiron Vision Corp. · Aug 1984
SITE COAXIAL I/A HANDPIECE 30 TIP
K840965 · Chiron Vision Corp. · May 1984
IOCARE IRRIGATION & ASPIRATION PACK
K834340 · Chiron Vision Corp. · Apr 1984
DISPOSABLE FIBER OPTIC ILLUMINATOR
K833465 · CooperVision, Inc. · Mar 1984