Cleared Traditional

SNAPDOSE DEVICE (K955410) - FDA 510(k) Clearance

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

K955410 · Abbott Laboratories · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1996
Decision
161d
Days
Class 2
Risk

K955410 is an FDA 510(k) clearance for the SNAPDOSE DEVICE. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on May 6, 1996 after a review of 161 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 Abbott Laboratories devices

Submission Details

510(k) Number K955410 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1995
Decision Date May 06, 1996
Days to Decision 161 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 129d · This submission: 161d
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 237
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K955410.
CONTINUFLO SOLUTION SET/SECONDARY MEDICATION SET
K961225 · Baxter Healthcare Corp · Jun 1996
ENERGIZED CONTAINER SYSTEM (MODIFICATION)
K954283 · Abbott Laboratories · May 1996
V2 INJECTION SITE
K955585 · B.Braun Medical, Inc. · 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