Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Avita Corporation — Predicate Candidate Screening

27 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

168 daysmedian FDA review time
463 days90th percentile
27clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K250129AViTA Breast PumpAvita Corporation2026-06-115100
K252448AViTA Pulse Oximeter (SP61)Avita Corporation2026-02-272070
K250765AViTA Arm Type Blood Pressure Monitor CuffAvita Corporation2025-09-031740
K242455AViTA Pulse Oximeter (SP62B)Avita Corporation2025-02-191840
K241852Nasal Aspirator (NS 13)Avita Corporation2024-12-311870
K242193Arm Type Blood Pressure Monitor (BPM82)Avita Corporation2024-10-22880
K223399AViTA Pulse OximeterAvita Corporation2024-05-205580
K200346Wrist Type Blood Pressure MonitorAvita Corporation2020-12-173100
K180155Arm Type Blood Pressure MonitorAvita Corporation2018-08-031960
K172427AViTA Radar Thermo NT16 Series IR ThermometerAvita Corporation2018-04-192520
K112825AVITA ARM TYPE BLOOD PRESSURE MONITORAvita Corporation2012-01-181120
K110559AVITA INFRARED THEROMETER WITH BLUETOOTHAvita Corporation2012-01-063120
K102554AVITA SCANEO IR THERMOMETER MODEL TS4X SERIESAvita Corporation2011-03-031770
K102624AVITA WRIST TYPE BLOOD PRESSURE MONITORAvita Corporation2010-12-16940
K090379AVITA NASAL ASPIRATOR, MODEL, NS1 SERIESAvita Corporation2010-05-264630
K100016AVITA SCANEO INFRARED EAR THERMOMETER, MODEL TS7Avita Corporation2010-03-04590
K092958AVITA SCANEO IR THERMOMETER, MODELS TS2X & TS3X SERIESAvita Corporation2009-12-02680
K092959AVITA RADAR THERMO IR THERMOMETER, MODEL NT 152Avita Corporation2009-11-27630
K081160AVITA RADAR THERMO IR THERMOMETER, NT1 SERIESAvita Corporation2008-06-24620
K072137AVITA BLUETOOTH BLOOD PRESSURE MONITOR, MODEL: BPM656ZBAvita Corporation2007-12-071270
K033397AVITA BPM6 SERIES BLOOD PRESSURE METER (OR MONITOR), MODEL BAvita Corporation2004-04-091680
K031503AVITA TS8/TS9 SERIES IR EAR/FOREHEAD THERMOMETERAvita Corporation2003-10-241640
K030230AVITA BPM1 SERIES (WRIST TYPE) BLOOD PRESSURE METER (OR MONIAvita Corporation2003-05-231210
K020738AVITA BF1 (VITALIO) BODY FAT ANALYZERAvita Corporation2003-05-224420
K012136AVITA AGIL IT 101 INSTANT DIGITAL THERMOMETERAvita Corporation2001-09-10630
K010462AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIEAvita Corporation2001-04-11540
K002182AVITA TSO/TS1 INFRARED EAR THERMOMETERAvita Corporation2000-12-291630

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda