# K970678: The Harvard Library

- Pathway: 510(k) (Traditional)
- Applicant: Harvard Apparatus, Inc.
- Decided: Jan 9, 1998 after 319 days
- Product code: MRZ (Accessories, Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Shasta Logic - Clinicalc: named in the summary without a submission number
- (no number) A Mixed Bag Corp - Infusion Calculator: named in the summary without a submission number
- (no number) Harvard Apparatus - Harvard 2 Syringe Pump: named in the summary without a submission number

## Indications for use
The Harvard Library is intended to provide a vehicle to create and download a library of drug names and parameters to the Harvard 2 Syringe Pump. It is designed to lessen the likelihood of operator errors when entering drug information into the Harvard 2 Syringe Pump.

Source page: https://510kreport.com/device/K970678
Methodology: https://510kreport.com/methodology