MEDLEY SYSTEM WITH BAR CODE MODULE, MODEL 8600— 510(k) K041241
Substantially EquivalentAlaris Medical Systems, Inc.
FDA 510(k) clearance K041241 for MEDLEY SYSTEM WITH BAR CODE MODULE, MODEL 8600, Substantially Equivalent on 2004-07-06. Applicant: Alaris Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Alaris Medical Systems, Inc.
- Product code
- Code FRN
- Device class
- Class 2
- Regulation
- 21 CFR 880.5725
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
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More clearances from Alaris Medical Systems, Inc.
view all- K043299 — MEDLEY PCA MODULE, MODEL 8120
- K031741 — MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300
- K032233 — MEDLEY PCA MODULE, MODEL 8120
- K032147 — SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS, MODELS 70XX, 71XX, 72XX, 7XXXX SERIES
- K030459 — MEDLEY SYSTEM WITH MEDICATION MANAGEMENT SYSTEM (MMS)
Adverse events under product code FRN
product code FRN- Death
- 540
- Injury
- 6,178
- Malfunction
- 1,464,165
- Other
- 52
- Total
- 1,470,935
Source: openFDA MAUDE database, through . 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 K041241
K-number listed on FDA's recall record- Z-1645-2026 — BD Alaris" System with Guardrails" Suite MX with Point of Care Unit
- Z-0534-2014 — Alaris PC unit model 8000 and 8015 with Alaris PCA module model 8120 and Auto ID barcode scanner model 8600. Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The Alaris PCA (Patient Controlled Analgesia) pump is one of the modules offer under the Alaris System. The Auto ID is a barcode scanner.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K041241.
Data sourced from openFDA. This site is unofficial and independent of the FDA.