Cleared Traditional

K991840 - FRESCO PHOSPHENE TONOMETER AND OR PHOSPHENE TONOMETER AND OR FPT AND OR EYELID TONOMETER

K991840 is an FDA 510(k) clearance for FRESCO PHOSPHENE TONOMETER AND OR PHOSP..., manufactured by Bernard B. Fresco. The device is a Class 2 Ophthalmic device with product code HKY cleared through the Traditional 510(k) pathway after a 297-day FDA review.

K991840 · Bernard B. Fresco · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2000
Decision
297d
Days
Class 2
Risk

K991840 is an FDA 510(k) clearance for the FRESCO PHOSPHENE TONOMETER AND OR PHOSPHENE TONOMETER AND OR FPT AND OR EYELI.... Classified as Tonometer, Manual (product code HKY), Class II - Special Controls.

Submitted by Bernard B. Fresco (Toronto, Ontario, CA). The FDA issued a Cleared decision on March 20, 2000 after a review of 297 days - an extended review 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: 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 Bernard B. Fresco devices

FDA 510(k) Submission Details - K991840

510(k) Number K991840 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1999
Decision Date March 20, 2000
Days to Decision 297 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
187d slower than avg
Panel avg: 110d · This submission: 297d
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 21
Devices cleared under the same product code (HKY) and FDA review panel - the closest regulatory comparables to K991840.
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K970887 · Paradigm Medical Industries, Inc. · Jun 1997
SCHIOTZ TONOMETER SPEC. 5 STRAIGHT, INCLINED, 3INCLINED SCALE
K945541 · Rudolf Riester GmbH & Co. KG · May 1995