BACTEC 9120 SYSTEM— 510(k) K922475
Substantially EquivalentBd Becton Dickinson Vacutainer Systems Preanalytic
FDA 510(k) clearance K922475 for BACTEC 9120 SYSTEM, Substantially Equivalent on 1992-07-01. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 1.
Clearance details
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Product code
- Code MDB
- Device class
- Class 1
- Regulation
- 21 CFR 866.2560
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Franklin Lakes, NJ, US
Recent devices under product code MDB
view allMore clearances from Bd Becton Dickinson Vacutainer Systems Preanalytic
view allAdverse events under product code MDB
product code MDB- Death
- 6
- Malfunction
- 5,490
- Total
- 5,496
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 K922475
K-number listed on FDA's recall record- Z-0237-2026 — BD BACTEC Blood Culture System, labeled as the following: 1. BACTEC 9120 System, Catalog Numbers: 445570, 445702. 2. INSTRUMENT BACTEC 9120 UNREPAIRED, Catalog Number: 44557008.
- Z-0595-2025 — BACTEC 9120 System Version or Model: 445570 Catalog Number: 445570
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K922475.
Data sourced from openFDA. This site is unofficial and independent of the FDA.