Cleared Traditional

K941883 - CONTACT LENS

K941883 is an FDA 510(k) clearance for CONTACT LENS, manufactured by Airperm, Inc.. The device is a Class 2 Ophthalmic device with product code HQD cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K941883 · Airperm, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 1994
Decision
193d
Days
Class 2
Risk

K941883 is an FDA 510(k) clearance for the CONTACT LENS. Classified as Lens, Contact (other Material) - Daily (product code HQD), Class II - Special Controls.

Submitted by Airperm, Inc. (Sherman Oaks, US). The FDA issued a Cleared decision on October 28, 1994 after a review of 193 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5916 - 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 - K941883

510(k) Number K941883 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1994
Decision Date October 28, 1994
Days to Decision 193 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
83d slower than avg
Panel avg: 110d · This submission: 193d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQD Device Classification - Class 2, Special Controls

Product Code HQD Lens, Contact (other Material) - Daily
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5916
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 - HQD Lens, Contact (other Material) - Daily

All 115
Devices cleared under the same product code (HQD) and FDA review panel - the closest regulatory comparables to K941883.
TRANS-AIRE RIGID GAS PERMEABLE CONTACT LENS
K952165 · Rand Scientific Corp. · Jun 1995
ROSE K LENS
K945955 · Rose K International , Ltd. · Feb 1995
ACCUCON
K944223 · Innovision, Inc. · Dec 1994
MELAFOCON A/RIGID GAS PERM CONTACT LEN FOR DAILY WEAR
K943784 · Menicon Co, Ltd. · Oct 1994
BOSTON(R) 7 - 30(ENFLUFOCON A)
K943177 · Polymer Technology Corp. · Aug 1994
NOVALENS/NOVAWET PERCEPTION AND VANGUARD
K942533 · Ocutec Corporation, Inc. · Aug 1994
K941883 · CONTACT LENS
Download PDF FDA Summary Airperm, Inc.