Cleared Traditional

K900217 - BARD MICROBORE ANTI-SIPHON NITRO SET

K900217 is the FDA 510(k) clearance for BARD MICROBORE ANTI-SIPHON NITRO SET by C.R. Bard, Inc.. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 287-day FDA review.

K900217 · C.R. Bard, Inc. · General Hospital
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Oct 1990
Decision
287d
Days
Class 2
Risk

K900217 is an FDA 510(k) clearance for the BARD MICROBORE ANTI-SIPHON NITRO SET. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (North Reading, US). The FDA issued a Cleared decision on October 31, 1990 after a review of 287 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - 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 C.R. Bard, Inc. devices

Submission Details

510(k) Number K900217 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1990
Decision Date October 31, 1990
Days to Decision 287 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
158d slower than avg
Panel avg: 129d · This submission: 287d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FRN Pump, Infusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 - FRN Pump, Infusion

All 433
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K900217.
STRATOFUSE PCA INFUSER
K905696 · Strato Medical Corp. · Mar 1991
BARD AMBULATORY PCA DRUG DELIVERY SYSTEM
K904403 · C.R. Bard, Inc. · Dec 1990
SYRINGE INFUSION PUMP
K903343 · Baxter Healthcare Corp · Nov 1990
IVAC(R) SYRINGE PUMP - MODEL 770
K901550 · Y · Oct 1990
IVAC(R) SYRINGE PUMP - MODEL 740
K903879 · Y · Oct 1990
MULTI DRUG INFUSION SYSTEM
K904048 · I-Flow Corp. · Oct 1990