INMAN MEDICAL OIL EMULSION DRESSING— 510(k) K921290

Name: FDA 510(k) clearance K921290
Creator: U.S. Food and Drug Administration
Published: 1992-11-23

Substantially Equivalent for Some Indications

Inman Medical Corp.

FDA 510(k) clearance K921290 for INMAN MEDICAL OIL EMULSION DRESSING, Substantially Equivalent for Some Indications on 1992-11-23. Applicant: Inman Medical Corp.. Device class: Unclassified.

Clearance details

Applicant: Inman Medical Corp.
Product code: Code FRO
Device class: Unclassified
Advisory panel: Unknown
Date received: 1992-03-11
Decision date: 1992-11-23
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Fort Worth, TX, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FRO

product code FRO

Death: 30
Injury: 653
Malfunction: 479
Other: 11
Total: 1,173

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K921290

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K921290.

Data sourced from openFDA. This site is unofficial and independent of the FDA.