Cleared Traditional

K780208 - ASPIRATOR, MANUEL

K780208 is an FDA 510(k) clearance for ASPIRATOR, manufactured by Dade, Baxter Travenol Diagnostics, Inc.. The device is a Class 1 Chemistry device with product code JQW cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K780208 · Dade, Baxter Travenol Diagnostics, Inc. · Chemistry device
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Mar 1978
Decision
24d
Days
Class 1
Risk

K780208 is an FDA 510(k) clearance for the ASPIRATOR, MANUEL. Classified as Station, Pipetting And Diluting, For Clinical Use (product code JQW), Class I - General Controls.

Submitted by Dade, Baxter Travenol Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 3, 1978 after a review of 24 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.

FDA 510(k) Submission Details - K780208

510(k) Number K780208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1978
Decision Date March 03, 1978
Days to Decision 24 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 89d · This submission: 24d
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 139
Devices cleared under the same product code (JQW) and FDA review panel - the closest regulatory comparables to K780208.
ADJUSTABLE DISPENSOR
K780912 · Oxford Laboratories, Inc. · Jun 1978
DILUTOR TRANSPORTER
K780785 · Hyland Therapeutic Div., Travenol Laboratories · Jun 1978
PERALISTIC PUMP MODEL 2000
K780789 · Innovative Medical Systems, Inc. · Jun 1978
PIPETTE, DISPENSING, MODEL ADP-30SD
K770772 · G.D. Searle and Co. · Jul 1977
PIPETTE, DILUTING, MODEL ADP-30SD
K770773 · G.D. Searle and Co. · Jul 1977
MICRO/PETTOR, SMI
K770307 · Lederle Laboratories · Apr 1977
K780208 · ASPIRATOR, MANUEL
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