Cleared Traditional

K840495 - MANUAL IRRIGATING/ASPIRATING UNIT

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

K840495 · Alltek, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K840495

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.

HQC Device Classification - Class 2, Special Controls

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 198
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
MICRO VIT FRAGMENTATION SYSTEM
K834537 · Medical Instrument Development Laboratories, Inc. · Mar 1984