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

Mchenry, IL, US

Rondex Products, Inc. appears in FDA device records in Mchenry, IL. FDA records list 11 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
11
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 11 510(k) clearances for Rondex Products, Inc. between 1984 and 1998. The busiest year on record is 1988, with 2. The most recent is 1998, with 1.

Clearances by year, as a table
510(k) clearance decisions for Rondex Products, Inc., by decision year
YearClearances
19841
19882
19902
19912
19921
19941
19951
19981
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K981169RONDEX CPR ISO-SHIELDCBPSubstantially Equivalent
K942671CPR SHIELDCBPSubstantially Equivalent
K943761NON-BREATHING VALVECBPUnknown
K921002RONDEX MASK MODELS 9122/9111/9102/911102, MODIFIEDBTMSubstantially Equivalent
K914196RONDEX MASKS MODELS 9015/9011/901102 MODIFIEDBTMSubstantially Equivalent
K914195RONDEX CPR NON REBREATHING VALVE #9030, MODIFIEDCBPSubstantially Equivalent
K902299CPR VALVE (NON-REBREATHING) MODEL #9030CBPSubstantially Equivalent
K902298ORAL-NASAL MASK RESUSCITATION AND ANESTHETIC GASBSJSubstantially Equivalent
K881931RESCUE MASK & CPR VALVE FOR MOUTH-TO-MASK TYPE CPRCBPSubstantially Equivalent
K881393RONDEX RESCUE MASKBSJSubstantially Equivalent
K834250RESCUE MASKBTMSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

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

Verification record

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What MDM checks, and what it does not

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