Cleared Traditional

K885340 - AIR DISPLACEMENT PIPETTE

K885340 is an FDA 510(k) clearance for AIR DISPLACEMENT PIPETTE, manufactured by Ulster Scientific, Inc.. The device is a Class 1 Chemistry device with product code JQW cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K885340 · Ulster Scientific, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1989
Decision
48d
Days
Class 1
Risk

K885340 is an FDA 510(k) clearance for the AIR DISPLACEMENT PIPETTE. Classified as Station, Pipetting And Diluting, For Clinical Use (product code JQW), Class I - General Controls.

Submitted by Ulster Scientific, Inc. (Highland, US). The FDA issued a Cleared decision on February 14, 1989 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2750 - the FDA in vitro diagnostics and chemistry 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 Ulster Scientific, Inc. devices

FDA 510(k) Submission Details - K885340

510(k) Number K885340 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1988
Decision Date February 14, 1989
Days to Decision 48 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 88d · This submission: 48d
Pathway characteristics
Predicate-based equivalence.

JQW Device Classification - Class 1, General Controls

Product Code JQW Station, Pipetting And Diluting, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2750
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JQW Station, Pipetting And Diluting, For Clinical Use

All 83
Devices cleared under the same product code (JQW) and FDA review panel - the closest regulatory comparables to K885340.
DU PONT DIMENSION PSID CLINICAL CHEMISTRY SYSTEM
K893775 · E.I. Dupont DE Nemours & Co., Inc. · Jul 1989
DELTA (TM) ROBOTIC PIPETTOR
K893031 · Diagnostic Products Corp. · Jun 1989
HI CHEM WASH CONCENTRATE REAGENT #88805
K890578 · Hichem Diagnostics · Mar 1989
IDS-1600 SAMPLE HANDLING SYSTEM
K883470 · Baxter Healthcare Corp · Dec 1988
DYNATECH SPD 2000, NUMBER 002-910-0000
K881195 · Dynatech Laboratories, Inc. · Jun 1988
MULTI-ACCESS REAGENT DISPENSER
K873416 · Electro-Nucleonics Laboratories, Inc. · Oct 1987