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

Lenexa, KS, US

VITALOGRAPH, INC. appears in FDA device records in Lenexa, KS. FDA records list 22 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
22
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 22 510(k) clearances for Vitalograph, Inc. between 1979 and 2025. The busiest year on record is 1995, with 3. The most recent is 2025, with 1.

Clearances by year, as a table
510(k) clearance decisions for Vitalograph, Inc., by decision year
YearClearances
19792
19832
19852
19861
19871
19882
19892
19911
19932
19941
19953
20002
20251
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K253293VitaloJAK Clinic (Model 7100)DSHSubstantially Equivalent
K000599VITALOGRAPH BASE STATIONBZGSubstantially Equivalent
K991412VITALOGRAPH MICROBZHSubstantially Equivalent
K943678ELECTRONIC FLOW METERBZHSubstantially Equivalent
K950854VITALOGRAPH 2110 SOFTWARE INTERFACEDSHSubstantially Equivalent
K946075VITALOGRAPH MODEL 2120BZGSubstantially Equivalent
K942779DISPOSABLE BACTERIOLOGICAL FILTERBZGSubstantially Equivalent
K925085ESCORT SPIROMETERBZGSubstantially Equivalent
K930085VITALOGRAPH DATA STORAGE SPIROMETERBTYSubstantially Equivalent
K912412VITALOGRAPH SPIROTRAC IIIBZGSubstantially Equivalent
K893665AEROSOL INHALATION MONITORBWFSubstantially Equivalent
K892524VITALOGRAPH-BREATHCO MONITORCCJSubstantially Equivalent
K873562VITALOGRAPH-ALPHABZGSubstantially Equivalent
K874892VITALOGRAPH-EC60 HYDROGEN MONITORNRHSubstantially Equivalent
K863420VITALOGRAPH EC-50 CARBON MONOXIDE MONITORCCJSubstantially Equivalent
K860949DUAL-AIDCAESubstantially Equivalent
K854526VITALOGRAPH COMPACTBZGSubstantially Equivalent
K844963VITAPEPBWFSubstantially Equivalent
K833785EMERGENCY ASPIRATORBTASubstantially Equivalent
K823683VITALOGRAPH PFT PRINTERBTYSubstantially Equivalent
K791503VITALOGRAPH FUNCTION ANALYZERBZCSubstantially Equivalent
K781922PULMONARY MONITORBZHSubstantially Equivalent

Registered establishments

FDA registered establishments for Vitalograph, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
19243051924305VITALOGRAPH, INC.13310 W. 99TH ST., Lenexa, KS 66215 US2026No device listings on this registration

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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