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

Newington, CT, US

ON SITE GAS SYSTEMS, INC. appears in FDA device records in Newington, CT. FDA records list 9 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
9
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 9 510(k) clearances for On Site Gas Systems Inc. between 2002 and 2010. The busiest year on record is 2002, with 5. The most recent is 2010, with 1.

Clearances by year, as a table
510(k) clearance decisions for On Site Gas Systems Inc., by decision year
YearClearances
20025
20042
20071
20101
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K092636POGS, MODEL 65/130CAWSubstantially Equivalent
K063454POGS, MODEL 33CCAWSubstantially Equivalent
K041664PORTABLE OXYGEN GENERATION SYSTEM: POGS 33CCAWSubstantially Equivalent
K030920POGS 33CAWSubstantially Equivalent
K021581HEMOSORBQSYSubstantially Equivalent
K013390QUICKCLOTQSYSubstantially Equivalent
K021082ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATION SYSTEM-1.0 AND 5.0CAWSubstantially Equivalent
K020362P.O.G.S. 3.3 PORTABLE OXYGEN GENERATOR SYSTEMCAWSubstantially Equivalent
K014078ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATOR SYSTEMCAWSubstantially Equivalent

Registered establishments

FDA registered establishments for On Site Gas Systems Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30036375743003637574ON SITE GAS SYSTEMS, INC.35 Budney Rd, Newington, CT 06111 US2026

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

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0647-2014On Site Gas Systems POGS 33C Portable Oxygen Generation SystemHeat exchanger hose becomes weak and may fail.Class IITerminated

Verification record

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