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

Bellevue, WA, US

Pascal International, Inc. appears in FDA device records in Bellevue, WA. FDA records list 8 510(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
8
PMA records
0
Recall records
1
Registered establishments
1

FDA records under these names

1 name

FDA records resolved to Pascal International, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Pascal Co., Inc.510(k), recall

510(k) clearance history

FDA records hold 8 510(k) clearances for Pascal International, Inc. between 1991 and 2010. The busiest year on record is 2003, with 2. The most recent is 2010, with 1.

Clearances by year, as a table
510(k) clearance decisions for Pascal International, Inc., by decision year
YearClearances
19911
19921
20032
20042
20091
20101
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K102526BLO2X OXYGEN BLOCKEREBFSubstantially Equivalent
K090597FLUORILAQ SODIUM FLUORIDE CAVITY VARNISHLBHSubstantially Equivalent
K040988ZIRCON-F PROPHYLAXIS PASTEEJRSubstantially Equivalent
K040661RADENT PROPHY PASTEEJRSubstantially Equivalent
K012889BANICIDE LIQUID CHEMICAL STERILANT/HIGH-LEVEL DISINFECTANTMEDSubstantially Equivalent
K030488FLUORILAQLBHSubstantially Equivalent
K912632OCCLUDEEFHSubstantially Equivalent
K911259HYDENTEFHSubstantially Equivalent

Registered establishments

FDA registered establishments for Pascal International, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30116323011632Pascal International, Inc.2929 Northup Way, Bellevue, WA 98004 US2026and 7 more, listed in full below

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-1588-05product labeled in part: ''***banicide ADVANCED, A Reusable Sterilizing & Disinfecting Solution***Active Ingredient: Glutaraldehyde (1,5 Pentanedial) 3.5%***NET CONTENTS: 3.8l (ONE U.S. GALLON)***Manufactured by Pascal Company, Inc. 2929 N.E. Northup Way P.O. Box 1478 Bellevue, WA 98009-1478 USA***''The product, Banicide Advanced, a resuable sterilizing and disinfecting solution, is likely to be ineffective for its intended use because testing found it failed testing for sporicidal use.Terminated

Verification record

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