Cleared Traditional

K921617 - CYLINDER OF GAS

K921617 is the FDA 510(k) clearance for CYLINDER OF GAS by Bio-Rad. It is a Class 2 Ophthalmic device (product code HKX) cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K921617 · Bio-Rad · Ophthalmic device
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Aug 1992
Decision
121d
Days
Class 2
Risk

K921617 is an FDA 510(k) clearance for the CYLINDER OF GAS, CAN OF GAS (CC12F2). Classified as Tonometer, Ac-powered (product code HKX), Class II - Special Controls.

Submitted by Bio-Rad (Glendale, US). The FDA issued a Cleared decision on August 5, 1992 after a review of 121 days - within the typical 510(k) review window.

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: 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 Bio-Rad devices

Submission Details

510(k) Number K921617 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1992
Decision Date August 05, 1992
Days to Decision 121 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 110d · This submission: 121d
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 22
Devices cleared under the same product code (HKX) and FDA review panel - the closest regulatory comparables to K921617.
CANON TX-10 TONOMETER
K963079 · Canon USA, Inc. · Mar 1997
NON-CONTACT TONOMETER T-2
K943939 · Canon, Inc. · May 1995
TIP & MEMBRANE ASSEMBLY
K921443 · Bio-Rad · Jun 1993
NIDEK MODEL NT-1000
K913189 · Nidek, Inc. · Oct 1991
KEELER PULSAIR NON CONTACT TONOMETER, MODIFICATION
K911721 · Keeler Instruments, Inc. · Jun 1991
BIO-RAD MODULAR AIR COMPRESSOR
K895575 · Bio-Rad · Oct 1989