Cleared Traditional

K935916 - LIP GRIP CAP HOLDER

K935916 is an FDA 510(k) clearance for LIP GRIP CAP HOLDER, manufactured by Daryl C. Fallas. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 694-day FDA review.

K935916 · Daryl C. Fallas · General Hospital
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Nov 1995
Decision
694d
Days
Class 2
Risk

K935916 is an FDA 510(k) clearance for the LIP GRIP CAP HOLDER. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Daryl C. Fallas (Deal, US). The FDA issued a Cleared decision on November 3, 1995 after a review of 694 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - the FDA general hospital 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 General Hospital submissions.

View all Daryl C. Fallas devices

FDA 510(k) Submission Details - K935916

510(k) Number K935916 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1993
Decision Date November 03, 1995
Days to Decision 694 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
565d slower than avg
Panel avg: 129d · This submission: 694d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMI Device Classification - Class 2, Special Controls

Product Code FMI Needle, Hypodermic, Single Lumen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
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 General Hospital devices follow this clearance model.

Regulatory Peers - FMI Needle, Hypodermic, Single Lumen

All 506
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