Cleared Traditional

K832175 - DIGILAB 350 THE KRAKAU PERIMETER

K832175 is an FDA 510(k) clearance for DIGILAB 350 THE KRAKAU PERIMETER, manufactured by Bio-Rad. The device is a Class 1 Ophthalmic device with product code HPT cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K832175 · Bio-Rad · Ophthalmic device
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Aug 1983
Decision
41d
Days
Class 1
Risk

K832175 is an FDA 510(k) clearance for the DIGILAB 350 THE KRAKAU PERIMETER. Classified as Perimeter, Automatic, Ac-powered (product code HPT), Class I - General Controls.

Submitted by Bio-Rad (Walker, US). The FDA issued a Cleared decision on August 16, 1983 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1605 - 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.

FDA 510(k) Submission Details - K832175

510(k) Number K832175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1983
Decision Date August 16, 1983
Days to Decision 41 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
69d faster than avg
Panel avg: 110d · This submission: 41d
Pathway characteristics
Predicate-based equivalence.

HPT Device Classification - Class 1, General Controls

Product Code HPT Perimeter, Automatic, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1605
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HPT Perimeter, Automatic, Ac-powered

All 40
Devices cleared under the same product code (HPT) and FDA review panel - the closest regulatory comparables to K832175.
QUANTUM 412
K844570 · Keta Corp. · Dec 1984
OCTOPUS 500/500E
K841099 · Cilco, Inc. · Jun 1984
OCUMAP 100 AUTOPERIMETER
K832555 · Shorashim · Feb 1984
DICON GLAUCOMA DIAG. CENTER 2000 SERIES
K832142 · CooperVision, Inc. · Aug 1983
MODEL 200 SQUID
K822853 · Synemed, Inc. · Oct 1982
AUTO PERIOMETER 3000
K822580 · Dicon, Inc. · Sep 1982
K832175 · DIGILAB 350 THE KRAKAU PERIMETER
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