Cleared Traditional

K972117 - MSI BOTTLEFLOW, TRANSFLOW, VIALFLOW

K972117 is an FDA 510(k) clearance for MSI BOTTLEFLOW, manufactured by Medical Specialty Innovations, Inc. (Msi). The device is a Class 2 General Hospital device with product code LHI cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K972117 · Medical Specialty Innovations, Inc. (Msi) · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
82d
Days
Class 2
Risk

K972117 is an FDA 510(k) clearance for the MSI BOTTLEFLOW, TRANSFLOW, VIALFLOW. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Medical Specialty Innovations, Inc. (Msi) (Great Neck, US). The FDA issued a Cleared decision on August 26, 1997 after a review of 82 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 Medical Specialty Innovations, Inc. (Msi) devices

FDA 510(k) Submission Details - K972117

510(k) Number K972117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1997
Decision Date August 26, 1997
Days to Decision 82 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
47d faster than avg
Panel avg: 129d · This submission: 82d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LHI Device Classification - Class 2, Special Controls

Product Code LHI Set, I.v. Fluid Transfer
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 - LHI Set, I.v. Fluid Transfer

All 89
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K972117.
CHEMO MINI SPIKE PLUS
K983794 · B. Braun of America, Inc. · Mar 1999
VIAL-MATE RECONSTITUTION DEVICE (2B8071)
K973654 · Baxter Healthcare Corp · Oct 1997
AUTOMIX 3+3/AS COMPOUNDER SYSTEM
K961008 · Baxter Healthcare Corp · Oct 1997
BAG DECANTER
K972134 · Remington Medical, Inc. · Aug 1997
AUTOMIX PLUS, 3+3, MICROMIX COMPOUNDING SYSTEM
K955622 · Baxter Healthcare Corp · May 1997
SAFE-CONNECT VIAL DISPENSING SPIKE
K970789 · Faulding Medical Device Co. · May 1997