Cleared Traditional

K970887 - BLOOD FLOW ANALYZER

K970887 is an FDA 510(k) clearance for BLOOD FLOW ANALYZER, manufactured by Paradigm Medical Industries, Inc.. The device is a Class 2 Ophthalmic device with product code HKY cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K970887 · Paradigm Medical Industries, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
98d
Days
Class 2
Risk

K970887 is an FDA 510(k) clearance for the BLOOD FLOW ANALYZER. Classified as Tonometer, Manual (product code HKY), Class II - Special Controls.

Submitted by Paradigm Medical Industries, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on June 17, 1997 after a review of 98 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.

FDA 510(k) Submission Details - K970887

510(k) Number K970887 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1997
Decision Date June 17, 1997
Days to Decision 98 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
12d faster than avg
Panel avg: 110d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HKY Device Classification - Class 2, Special Controls

Product Code HKY Tonometer, Manual
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 - HKY Tonometer, Manual

All 49
Devices cleared under the same product code (HKY) and FDA review panel - the closest regulatory comparables to K970887.
FRESCO PHOSPHENE TONOMETER AND OR PHOSPHENE TONOMETER AND OR FPT AND OR EYELID TONOMETER
K991840 · Bernard B. Fresco · Mar 2000
AUTOMATED OPHTHALMICS SOFTIPS
K992998 · Automated Ophthalmics, Inc. · Jan 2000
GOLDMAN MANUAL TONOMETER
K981432 · Golden Vision, Inc. · Jan 1999
MENTOR TONO-PEN 3
K964312 · Mentor Ophthalmics, Inc. · Nov 1996
PERKINS HAND-HELD APPLANATION TONOMETER
K961512 · Clement Clarke, Inc. · Jul 1996
KOWA HAND-HELD APPLANATION TONOMETER HA-1
K960924 · Kowa Optimed, Inc. · Jun 1996
K970887 · BLOOD FLOW ANALYZER
Download PDF FDA Summary Paradigm Medical Indu…