Cleared Traditional

LANGHAM OCULAR BLOOD FLOW (OBF) TONOGRAPH/TONOMETER MODEL 201 (K010998) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K010998 · Langham Ophthalmic Technologies · Ophthalmic device
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Jun 2001
Decision
85d
Days
Class 2
Risk

K010998 is an FDA 510(k) clearance for the LANGHAM OCULAR BLOOD FLOW (OBF) TONOGRAPH/TONOMETER MODEL 201. Classified as Tonometer, Ac-powered (product code HKX), Class II - Special Controls.

Submitted by Langham Ophthalmic Technologies (Timonium, US). The FDA issued a Cleared decision on June 27, 2001 after a review of 85 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 Langham Ophthalmic Technologies devices

Submission Details

510(k) Number K010998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received April 03, 2001
Decision Date June 27, 2001
Days to Decision 85 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
25d faster than avg
Panel avg: 110d · This submission: 85d
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 57
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