Atlas FDA

PURITAN BENNETT 980 SERIES VENTILATOR SYSTEM

FDA 510(k) clearance K131252 · decided 2014-02-24

Clearance details

K-number
K131252
Device name
PURITAN BENNETT 980 SERIES VENTILATOR SYSTEM
Applicant
Covidien
Decision
Substantially Equivalent
Date received
2013-05-02
Decision date
2014-02-24
Days to decision
298 days
Clearance type
Traditional
Product code
CBK
Device class
2
Regulation number
868.5895
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Boulder, CO, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Puritan Bennett 980 Ventilator System, PB980 Ventilator (980xxxxxxxx). Intended to provide recall (Z-1181-2016)Covidien LP (formerly Nellcor Puritan Bennett Inc.)2016-03-17
Puritan Bennett 980 Ventilator System, Universal (with neonatal functionality enabled) and recall (Z-2329-2015)Covidien LP (formerly Nellcor Puritan Bennett Inc.)2015-08-14
Puritan Bennett 980 Ventilator System, Model No. PB980 Ventilator (980xxxxxxxx), The Purit recall (Z-1058-2015)Covidien LP (formerly Nellcor Puritan Bennett Inc.)2015-02-05
Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF recall (Z-0180-2015)Nellcor Puritan Bennett Inc. (dba Covidien LP)2014-12-09
Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (inst recall (Z-0112-2015)Nellcor Puritan Bennett Inc. (dba Covidien LP)2014-10-28

PMA approvals by this applicant

RecordFirmDate
MODEL 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034/S006)Covidien1997-06-24
MODEL 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034/S005)Covidien1995-12-28
MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034/S004)Covidien1995-06-14
MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034/S003)Covidien1994-06-17
MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034/S002)Covidien1994-03-28
MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034/S001)Covidien1993-09-10
MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034)Covidien1991-12-13