Cleared Traditional

K924277 - DISPOSABLE HYPODERMIC MONOPLAR NEEDLE R...

K924277 is an FDA 510(k) clearance for DISPOSABLE HYPODERMIC MONOPLAR NEEDLE R..., manufactured by Chalgren Enterprises, Inc.. The device is a Class 2 Ophthalmic device with product code HLT cleared through the Traditional 510(k) pathway after a 834-day FDA review.

K924277 · Chalgren Enterprises, Inc. · Ophthalmic device
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Dec 1994
Decision
834d
Days
Class 2
Risk

K924277 is an FDA 510(k) clearance for the DISPOSABLE HYPODERMIC MONOPLAR NEEDLE RECORDING. Classified as Preamplifier, Ac-powered, Ophthalmic (product code HLT), Class II - Special Controls.

Submitted by Chalgren Enterprises, Inc. (Gilroy, US). The FDA issued a Cleared decision on December 7, 1994 after a review of 834 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1640 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Ophthalmic submissions.

View all Chalgren Enterprises, Inc. devices

FDA 510(k) Submission Details - K924277

510(k) Number K924277 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1992
Decision Date December 07, 1994
Days to Decision 834 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
724d slower than avg
Panel avg: 110d · This submission: 834d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HLT Device Classification - Class 2, Special Controls

Product Code HLT Preamplifier, Ac-powered, Ophthalmic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1640
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.