Cleared Traditional

K813644 - MODEL 2650 HIGH CAPACITY DUAL SYRINGE

K813644 is an FDA 510(k) clearance for MODEL 2650 HIGH CAPACITY DUAL SYRINGE, manufactured by Harvard Apparatus, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K813644 · Harvard Apparatus, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1982
Decision
49d
Days
Class 2
Risk

K813644 is an FDA 510(k) clearance for the MODEL 2650 HIGH CAPACITY DUAL SYRINGE. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Harvard Apparatus, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 18, 1982 after a review of 49 days - a notably fast clearance 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: 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 Harvard Apparatus, Inc. devices

FDA 510(k) Submission Details - K813644

510(k) Number K813644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 1981
Decision Date February 18, 1982
Days to Decision 49 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
80d faster than avg
Panel avg: 129d · This submission: 49d
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 528
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K813644.
VOLUMETRIC PUMP CASSETTE W/ATTACHED SET
K820860 · Travenol Laboratories, S.A. · Apr 1982
IVAC MODEL 160 AIR-IN-LINE SENSOR
K820764 · Y · Apr 1982
ACCU-RYNGE INSULIN PUMP #SP-250
K820482 · Delta Medical Industries · Mar 1982
MODEL AS6B INFUSION PUMP
K813590 · Baxter Healthcare Corp · Jan 1982
OPEN LOOP AMBULATORY INSULIN INFUSION
K820073 · Cardiac Pacemakers, Inc. · Jan 1982
5B SLAVE MODULE SYRINGE PUMP
K813473 · Baxter Healthcare Corp · Jan 1982