Cleared Traditional

NIMA (NEEDLELESS INJECTIONSITE MASTER ADAPTER) & I.V. SET (K952852) - FDA 510(k) Clearance

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

K952852 · Critical Device Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
240d
Days
Class 2
Risk

K952852 is an FDA 510(k) clearance for the NIMA (NEEDLELESS INJECTIONSITE MASTER ADAPTER) & 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 16, 1996 after a review of 240 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 Critical Device Corp. devices

Submission Details

510(k) Number K952852 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1995
Decision Date February 16, 1996
Days to Decision 240 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
111d slower than avg
Panel avg: 129d · This submission: 240d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 228
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K952852.
ENERGIZED CONTAINER SYSTEM (MODIFICATION)
K954283 · Abbott Laboratories · May 1996
V2 INJECTION SITE
K955585 · B.Braun Medical, Inc. · May 1996
SNAPDOSE DEVICE
K955410 · Abbott Laboratories · May 1996
LOW PROFILE SAFSITE Y-SITE
K954123 · B.Braun Medical, Inc. · Nov 1995
LIFESHIELD LUER ACTIVATED VALVE MALE ADAPTER PLUG
K953584 · Abbott Laboratories · Oct 1995
SOLUTION SET WITH 1.2 MICRON AIR ELIMINATING FILTER
K952074 · Baxter Healthcare Corp · Jul 1995