Cleared Traditional

K911721 - KEELER PULSAIR NON CONTACT TONOMETER

K911721 is the FDA 510(k) clearance for KEELER PULSAIR NON CONTACT TONOMETER by Keeler Instruments, Inc.. It is a Class 2 Ophthalmic device (product code HKX) cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K911721 · Keeler Instruments, Inc. · Ophthalmic device
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Jun 1991
Decision
69d
Days
Class 2
Risk

K911721 is an FDA 510(k) clearance for the KEELER PULSAIR NON CONTACT TONOMETER, MODIFICATION. Classified as Tonometer, Ac-powered (product code HKX), Class II - Special Controls.

Submitted by Keeler Instruments, Inc. (Broomall, US). The FDA issued a Cleared decision on June 25, 1991 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1930 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Keeler Instruments, Inc. devices

Submission Details

510(k) Number K911721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1991
Decision Date June 25, 1991
Days to Decision 69 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 110d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HKX Tonometer, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1930
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 - HKX Tonometer, Ac-powered

All 20
Devices cleared under the same product code (HKX) and FDA review panel - the closest regulatory comparables to K911721.
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KEELER PULSAIR NON CONTACT TONOMETER
K870750 · Keeler Instruments, Inc. · Mar 1987
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K870121 · Bio-Rad · Feb 1987