510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Caire Diagnostics, Inc.

Pleasanton, CA, US

Caire Diagnostics, Inc. appears in FDA device records in Pleasanton, CA. FDA records list one 510(k) clearance, no PMA records and no registered establishments. As of , FDA records show one recall for this company.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
1
Registered establishments
0

510(k) clearance history

FDA records hold 1 510(k) clearance for Caire Diagnostics, Inc. in 2023.

Clearances by year, as a table
510(k) clearance decisions for Caire Diagnostics, Inc., by decision year
YearClearances
20231
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K213611Fenom ProMXASubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1284-2021CAIRE DIAGNOSTICS FenomPro REF 900-0001 SN ***** - Product Usage: a portable, non-invasive device to measure fractional exhaled nitric oxide (FeNO) in human breath. Fenom Pro should not be used in critical care, emergency care or in anesthesiology.Erroneously high FeNO levels which may contribute to premature discontinuation of effective asthma treatment and persistent underlying disease. Two issues affecting the FeNO readings: 1) Drift in the calibration gases and 2) Software error. Each of these issues can cause FeNO scores/results to be erroneously high.Class IITerminated

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Data as of , FDA export datePage updated Source: openFDA, public domain