Cleared Traditional

K895575 - BIO-RAD MODULAR AIR COMPRESSOR

K895575 is the FDA 510(k) clearance for BIO-RAD MODULAR AIR COMPRESSOR by Bio-Rad. It is a Class 2 Ophthalmic device (product code HKX) cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K895575 · Bio-Rad · Ophthalmic device

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Oct 1989

Decision

47d

Days

Class 2

Risk

K895575 is an FDA 510(k) clearance for the BIO-RAD MODULAR AIR COMPRESSOR. Classified as Tonometer, Ac-powered (product code HKX), Class II - Special Controls.

Submitted by Bio-Rad (Cambridge, US). The FDA issued a Cleared decision on October 31, 1989 after a review of 47 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 Bio-Rad devices

Submission Details

510(k) Number	K895575 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 14, 1989
Decision Date	October 31, 1989
Days to Decision	47 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

63d faster than avg

Panel avg: 110d · This submission: 47d

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 K895575.

CYLINDER OF GAS, CAN OF GAS (CC12F2)

K921617 · Bio-Rad · Aug 1992

NIDEK MODEL NT-1000

K913189 · Nidek, Inc. · Oct 1991

KEELER PULSAIR NON CONTACT TONOMETER, MODIFICATION

K911721 · Keeler Instruments, Inc. · Jun 1991

KEELER PULSAIR NON CONTACT TONOMETER

K870750 · Keeler Instruments, Inc. · Mar 1987

DIGILAB MICRO ONE APPLANATION TONOMETER

K870121 · Bio-Rad · Feb 1987

DIGILAB MODULAR ONE-APPLANATION TONOMETER

K863217 · Bio-Rad · Sep 1986

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K895575

Bio-Rad

Cambridge, MA · US

DAVID P MACADAM

Regulatory profile

319 submissions 319 cleared

100% clearance rate · Active in Ophthalmic

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Sourced from FDA 510(k) public files . Updated monthly.

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