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

Englewood, CO, US

IPAX, INC. appears in FDA device records in Englewood, CO. FDA records list 16 510(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
16
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 16 510(k) clearances for Ipax, Inc. between 1986 and 2021. The busiest year on record is 1986, with 5. The most recent is 2021, with 1.

Clearances by year, as a table
510(k) clearance decisions for Ipax, Inc., by decision year
YearClearances
19865
19873
19881
19913
19921
19972
20211
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K200893ProntoPump Sterile Tube SetLHISubstantially Equivalent
K971242BLINK GOLD EVELID WEIGHT (BG 06 THRU BG 28)MMLSubstantially Equivalent
K971245BLINK EXTERNAL EYELID WEIGHTMMLSubstantially Equivalent
K915158SUREBREATH DOME, E-Z BREATHERGADSubstantially Equivalent
K915118PHACO EMULSIFICATION,IRRIGATION/ASPIRATION TUBEHQCSubstantially Equivalent
K914221KPE 220 TS, NONSTERILEHQESubstantially Equivalent
K914172KPE 230 AMHQCSubstantially Equivalent
K884076SUREBREATH DOMEGADSubstantially Equivalent
K873097PROCEDUAL CHANGES/ASSEMBLY PROCESS FOR PLUS PAKSGBQSubstantially Equivalent
K870770TIMLEINE(TM) VENIPUNCTURE SYSTEMKMKSubstantially Equivalent
K864726I/A/KPE TIPHQCSubstantially Equivalent
K863729OPHTHALMIC FITLER MICRO CAPSULEHQCSubstantially Equivalent
K863209US PLUS-PAK(R) SURGICAL SYSTEMHQCSubstantially Equivalent
K862334CATALOG NO. I/A 100 AND KPE 200Substantially Equivalent
K861182TIMELINE VENIPUNCTURE SYSTEMFPASubstantially Equivalent
K860609TIMELINE VENIPUNCTURE SYSTEMFPASubstantially Equivalent

Registered establishments

FDA registered establishments for Ipax, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
17207341720734IPAX, INC.2700 S Raritan St, Englewood, CO 80110 US2026and 1 more, listed in full below

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