Cleared Traditional

K880857 - SYRINGE PUMP MS2000

K880857 is an FDA 510(k) clearance for SYRINGE PUMP MS2000, manufactured by Smash Ent., Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K880857 · Smash Ent., Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1988
Decision
184d
Days
Class 2
Risk

K880857 is an FDA 510(k) clearance for the SYRINGE PUMP MS2000. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Smash Ent., Inc. (Arden Hills, US). The FDA issued a Cleared decision on September 1, 1988 after a review of 184 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 Smash Ent., Inc. devices

FDA 510(k) Submission Details - K880857

510(k) Number K880857 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1988
Decision Date September 01, 1988
Days to Decision 184 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 129d · This submission: 184d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRN Device Classification - Class 2, Special Controls

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 603
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K880857.
UVP VOLUMED 2001
K881079 · Ferguson Medical · Oct 1988
MULTI-DRUG INFUSION SYSTEM
K883003 · I-Flow Corp. · Oct 1988
BECTON DICKINSON PCA INFUSER - SOFTWARE MODIFI.
K882556 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1988
BARD PCA II INFUSION PUMP
K880733 · C.R. Bard, Inc. · Jun 1988
IVAC VOLUMETRIC PUMP - MODEL 590
K875332 · Y · May 1988
SIM MODULE
K874546 · Critikon Company, LLC · May 1988