Cleared Traditional

K964812 - NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER AND I.V. SET

K964812 is an FDA 510(k) clearance for NIMA NEEDLELESS INJECTIONSITE MASTER AD..., manufactured by Critical Device Corp.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K964812 · Critical Device Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
73d
Days
Class 2
Risk

K964812 is an FDA 510(k) clearance for the NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER AND I.V. SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Critical Device Corp. (Brea, US). The FDA issued a Cleared decision on February 10, 1997 after a review of 73 days - a notably fast clearance 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: 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 Critical Device Corp. devices

FDA 510(k) Submission Details - K964812

510(k) Number K964812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1996
Decision Date February 10, 1997
Days to Decision 73 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 129d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPA Device Classification - Class 2, Special Controls

Product Code FPA Set, Administration, Intravascular
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 - FPA Set, Administration, Intravascular

All 644
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K964812.
MR EXTENSION SET (001)
K964968 · University of Michigan · Feb 1997
SOLUTION ADMINISTRATION SET WITH 0.22 MICRON HIGH PRESSURE EXTENDED LIFE FILTER
K964850 · Baxter Healthcare Corp · Feb 1997
VYGON BIONECTOR WITH EXTENSION SET
K963981 · Vygon Corp. · Feb 1997
POLYFIN WITH WINGS INFUSION SETS, MODELS 306, 307, 333
K964455 · Medtronic Minimed · Jan 1997
POLYFIN QR WITH WINGS INFUSION SETS, MODELS 365, 366, AND 367
K964456 · Medtronic Minimed · Jan 1997
MODEL D-290P ADMINISTRATION SET
K964384 · Patient Solutions, Inc. · Jan 1997