Cleared Traditional

K810317 - NITROGLYCERINE IV SET

K810317 is an FDA 510(k) clearance for NITROGLYCERINE IV SET, manufactured by Abbott Laboratories. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K810317 · Abbott Laboratories · General Hospital
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May 1981
Decision
110d
Days
Class 2
Risk

K810317 is an FDA 510(k) clearance for the NITROGLYCERINE IV SET. 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 27, 1981 after a review of 110 days - within the typical 510(k) review window.

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

FDA 510(k) Submission Details - K810317

510(k) Number K810317 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1981
Decision Date May 27, 1981
Days to Decision 110 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 129d · This submission: 110d
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 532
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K810317.
AUTO-SYRINGE MICRO VOLUME EXTENSION SET
K811463 · Baxter Healthcare Corp · Jun 1981
MODELS: 52-01-0, 52-01-1
K811110 · Y · Jun 1981
VENTED PRIMARY PIGGYBACK VENOSET DUAL
K810239 · Abbott Laboratories · May 1981
HAEMONETICS 170 Y INFUSION SET
K810365 · Haemonetics Corp. · Mar 1981
PRIMARY SOLUTION ADMIN. SET-#86-01-0 260
K801871 · Y · Aug 1980
MODEL 86-01-1 260 SOLUTION ADMIN. SET
K801872 · Y · Aug 1980