Clearance details

Applicant: Advantage Medical Systems, Inc.
Product code: Code FMI
Device class: Class 2
Regulation: 21 CFR 880.5570
Advisory panel: General Hospital
Date received: 1987-09-28
Decision date: 1987-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Horsham, PA, US

Recent devices under product code FMI

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K261719 — Promisemed X-Safety Pen Needle2026-08-25
K262427 — Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)2026-08-10
K260933 — Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)2026-08-07
K261829 — Profoject Dual-Safety Pen Needles2026-07-29
K260739 — Profoject Pen Needles (Model A; Model B)2026-07-15

More clearances from Advantage Medical Systems, Inc.

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K873290 — LACERATION AND INSTRUMENT TRAYS1987-09-24
K863494 — NEONATAL PHYSIOLOGICAL MONITOR MODEL PM 201986-12-22
K861556 — MODIFIED FETAL MONITOR MODEL FM-21986-07-07
K861279 — FLUORO PLUS1986-06-16
K861455 — MODEL DT-102 DATA TELEPHONE TRANSMITTER1986-05-30

Adverse events under product code FMI

product code FMI

Death: 28
Injury: 1,517
Malfunction: 23,981
Other: 18
Total: 25,544

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 K873957

K-number listed on FDA's recall record

Z-0681-2018 — 19Ga x 1 Huber Needle Set. Product Code: MBS-1910.Class II·Terminated·Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.·20170724

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K873957.