FDA 510(k) clearance · back to tracker

SUCTION CATHETER KIT, STERILE, SINGLE-USE

Trinity Laboratories, Inc. cleared K951506 on 1995-07-03, decision: substantially equivalent

K-number

K951506

Sponsor

Trinity Laboratories, Inc.

Device

SUCTION CATHETER KIT, STERILE, SINGLE-USE

Class

Class I

Decision

Substantially Equivalent

Decision date

1995-07-03

Product code

BSY

Advisory committee

Anesthesiology

Medical specialty

Anesthesiology

Regulation number

868.6810

Official FDA record

Open K951506on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

Use this as a predicate

Drop K951506 into Compass and start a substantial-equivalence draft.

Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.