BACTEC 9240 SYSTEM— 510(k) K915796
Substantially EquivalentBd Becton Dickinson Vacutainer Systems Preanalytic
FDA 510(k) clearance K915796 for BACTEC 9240 SYSTEM, Substantially Equivalent on 1992-04-22. 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
- Roswell, GA, 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 K915796
K-number listed on FDA's recall record- Z-0236-2026 — BD BACTEC Blood Culture System, labeled as the following: 1. BD BACTEC FX, Instrument Top, Packaged, Catalog Number: 44138509. 2. Instrument Top Remanufactured Bactec Fx, Catalog Number: 441676. 3. BACTEC 9240 System, Catalog Number: 445569. 4. BD BACTEC FX40 Instrument, Catalog Number: 44229609.
- Z-0593-2025 — BD BACTEC FX, Instrument Top, Packaged Version or Model: 441385 Catalog Number: 441385
- Z-0594-2025 — BD BACTEC FX40 Instrument Version or Model: 442296 Catalog Number: 442296
- Z-0596-2025 — BACTEC 9240 System Version or Model: 445475 Catalog Number: 445475
- Z-0869-2014 — BD BACTEC FX- Top Unit instrument, catalog number 441385, and Bottom Unit instrument, catalog 441386, available as a single or a stack configuration; Manufactured by BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD 21152. The BD BACTEC FX instrument is designed for the rapid detection of bacteria and fungi in clinical specimens. Samples are drawn from patients and injected directly into BACTEC culture vials, which are placed into the instrument for incubation and testing.
- Z-0870-2014 — BD BACTEC FX 40 instrument, catalog number 442296, manufactured by BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD 21152. The instrument is designed for the rapid detection of bacteria and fungi in clinical specimens. Samples are drawn from patients and injected directly into BACTEC culture vials, which are placed into the instrument for incubation and testing.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K915796.
Data sourced from openFDA. This site is unofficial and independent of the FDA.