Cleared Traditional

K980180 - 2700 SAMPLE MANAGER

K980180 is an FDA 510(k) clearance for 2700 SAMPLE MANAGER, manufactured by Waters Corporation. The device is a Class 1 Toxicology device with product code JQW cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K980180 · Waters Corporation · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
23d
Days
Class 1
Risk

K980180 is an FDA 510(k) clearance for the 2700 SAMPLE MANAGER. Classified as Station, Pipetting And Diluting, For Clinical Use (product code JQW), Class I - General Controls.

Submitted by Waters Corporation (Milford, US). The FDA issued a Cleared decision on February 12, 1998 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.2750 - the FDA toxicology 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 Waters Corporation devices

FDA 510(k) Submission Details - K980180

510(k) Number K980180 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 1998
Decision Date February 12, 1998
Days to Decision 23 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 87d · This submission: 23d
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 K980180.
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