Atlas FDA

BACTEC 9240 SYSTEM

FDA 510(k) clearance K915796 · decided 1992-04-22

Clearance details

K-number
K915796
Device name
BACTEC 9240 SYSTEM
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
Decision
Substantially Equivalent
Date received
1991-12-24
Decision date
1992-04-22
Days to decision
120 days
Clearance type
Traditional
Product code
MDB
Device class
1
Regulation number
866.2560
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Roswell, GA, US
Third-party review
No
Expedited review
No

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BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial (K161810)Becton Dickinson2017-02-09
BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial (K161306)Becton Dickinson2016-08-08
BD BACTEC Peds Plus/F Culture Vials (plastic) (K151866)Becton, Dickinson and Company2016-02-25
BD BACTEC PLUS ANAEROBIC/F (PLASTIC) (K141810)Becton, Dickinson and Company2014-12-10
BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic) (K123903)Becton, Dickinson & CO2013-05-13

Recalls involving this device

RecordFirmDate
BD BACTEC Blood Culture System, labeled as the following: 1. BD BACTEC FX, Instrument Top, recall (Z-0236-2026)Becton Dickinson & Co.2025-10-23
BD BACTEC FX, Instrument Top, Packaged Version or Model: 441385 Catalog Number: 441385 recall (Z-0593-2025)Becton Dickinson & Co.2024-12-03
BD BACTEC FX40 Instrument Version or Model: 442296 Catalog Number: 442296 recall (Z-0594-2025)Becton Dickinson & Co.2024-12-03
BACTEC 9240 System Version or Model: 445475 Catalog Number: 445475 recall (Z-0596-2025)Becton Dickinson & Co.2024-12-03
BD BACTEC FX- Top Unit instrument, catalog number 441385, and Bottom Unit instrument, cata recall (Z-0869-2014)Becton Dickinson & Co.2014-01-30
BD BACTEC FX 40 instrument, catalog number 442296, manufactured by BD Diagnostic Systems, recall (Z-0870-2014)Becton Dickinson & Co.2014-01-30

PMA approvals by this applicant

RecordFirmDate
OXYCELL (N5798/S007)Bd Becton Dickinson Vacutainer Systems Preanalytic1995-07-24
OXYCEL OXIDIZED (N5798/S005)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-02-08
OXYCELL (N5798/S006)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-02-08
MINI BALLOON (P780011/S012)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-10-30
MINI BALLOON (P780011/S011)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-10-18
MINI BALLOON (P780011/S010)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-01-29
MINI BALLOON (P780011/S007)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-01-23
BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC (P800030/S006)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-11-05