MECONIUM SUCTION TRAP— 510(k) K862181

Name: FDA 510(k) clearance K862181
Creator: U.S. Food and Drug Administration
Published: 1986-08-13

Substantially Equivalent

Michael Reese Hospital and Medical Center

FDA 510(k) clearance K862181 for MECONIUM SUCTION TRAP, Substantially Equivalent on 1986-08-13. Applicant: Michael Reese Hospital and Medical Center. Device class: 1.

Clearance details

Applicant: Michael Reese Hospital and Medical Center
Product code: Code BSY
Device class: Class 1
Regulation: 21 CFR 868.6810
Advisory panel: Anesthesiology
Date received: 1986-06-09
Decision date: 1986-08-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BSY

view all

K031997 — MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEM2003-11-25
K992902 — AMBU HAND POWER SUCTION PUMP1999-10-25
K982945 — DUAL PURPOSE CLOSED CATHETER1998-09-22
K981910 — SUCTION CATHETER1998-08-24
K972258 — HI-CARE CLOSED SUCTION SYSTEM1997-12-29

More clearances from Michael Reese Hospital and Medical Center

view all

K862182 — AMNIOINFUSION CATHETER1986-08-25

Adverse events under product code BSY

product code BSY

Death: 3
Injury: 155
Malfunction: 959
Total: 1,117

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 →

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