Cleared Traditional

K945446 - BOBES TONOMETER

K945446 is an FDA 510(k) clearance for BOBES TONOMETER, manufactured by Bobes S.A.. The device is a Class 2 Ophthalmic device with product code HKY cleared through the Traditional 510(k) pathway after a 225-day FDA review.

K945446 · Bobes S.A. · Ophthalmic device
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Jun 1995
Decision
225d
Days
Class 2
Risk

K945446 is an FDA 510(k) clearance for the BOBES TONOMETER. Classified as Tonometer, Manual (product code HKY), Class II - Special Controls.

Submitted by Bobes S.A. (Madrid, ES). The FDA issued a Cleared decision on June 20, 1995 after a review of 225 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 Bobes S.A. devices

FDA 510(k) Submission Details - K945446

510(k) Number K945446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1994
Decision Date June 20, 1995
Days to Decision 225 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
115d slower than avg
Panel avg: 110d · This submission: 225d
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 41
Devices cleared under the same product code (HKY) and FDA review panel - the closest regulatory comparables to K945446.
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
SCHIOTZ TONOMETER SPEC. 5 STRAIGHT, INCLINED, 3INCLINED SCALE
K945541 · Rudolf Riester GmbH & Co. KG · May 1995
TONOSHIELD TONOMETER SHIELD
K923877 · Oasis Medical, Inc. · Sep 1992
JAKOBI SURG. INSTRUMENTS #6 50
K834187 · Imm Enterprises , Ltd. · Mar 1984