Cleared Traditional

K921031 - EDGE MEDICAL DISPENSING PIN

K921031 is an FDA 510(k) clearance for EDGE MEDICAL DISPENSING PIN, manufactured by Edgewater Medical Center. The device is a Class 2 General Hospital device with product code LHI cleared through the Traditional 510(k) pathway after a 230-day FDA review.

K921031 · Edgewater Medical Center · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1992
Decision
230d
Days
Class 2
Risk

K921031 is an FDA 510(k) clearance for the EDGE MEDICAL DISPENSING PIN. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Edgewater Medical Center (Beverly Hills, US). The FDA issued a Cleared decision on October 19, 1992 after a review of 230 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Edgewater Medical Center devices

FDA 510(k) Submission Details - K921031

510(k) Number K921031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1992
Decision Date October 19, 1992
Days to Decision 230 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
101d slower than avg
Panel avg: 129d · This submission: 230d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LHI Device Classification - Class 2, Special Controls

Product Code LHI Set, I.v. Fluid Transfer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - LHI Set, I.v. Fluid Transfer

All 152
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K921031.
DIPRIVAN LUER CONNECTOR
K935274 · Ohmeda Medical · Mar 1994
INTERLINK UNIVERSAL VIAL ADAPTER
K924064 · Baxter Healthcare Corp · Apr 1993
IV FLUID TRANSFER PIN
K925401 · B. Braun of America, Inc. · Mar 1993
NUTRIMIX MICROCOMPOUNDER
K921365 · Abbott Laboratories · Jun 1992
ACACIAS PHARM/PUMP
K912771 · Acacia, Inc. · Feb 1992
NUTRIMIX(R) MACRO(TM) TPN COMPOUNDER/MODIFICATION
K910213 · Abbott Laboratories · Apr 1991