Pascal Co., Inc.

FDA Regulatory Profile

Pascal Co., Inc. has 0 FDA recalls, 6 inspections, 8 510(k) clearances and 0 compliance actions on record.

Latest inspection
Aug 21, 2025 · NAI
Latest 510(k)
Oct 22, 2010

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances8Nov 8, 2026File dated Nov 2, 2026Current
Inspections6Nov 10, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Aug 21, 2025Bellevue, WADevicesNo Action Indicated (NAI)3011632
Mar 5, 2018Bellevue, WADevicesNo Action Indicated (NAI)3011632
Aug 31, 2016Bellevue, WADevicesNo Action Indicated (NAI)3011632
Feb 25, 2013Bellevue, WADevicesNo Action Indicated (NAI)3011632
Aug 3, 2011Bellevue, WADrugsNo Action Indicated (NAI)3011632
Apr 21, 2011Bellevue, WADevicesNo Action Indicated (NAI)3011632

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 3011632Bellevue, WA6Aug 21, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K102526BLO2X OXYGEN BLOCKEROct 22, 2010
K090597FLUORILAQ SODIUM FLUORIDE CAVITY VARNISHMar 16, 2009
K040988ZIRCON-F PROPHYLAXIS PASTEJul 7, 2004
K040661RADENT PROPHY PASTEJun 9, 2004
K012889BANICIDE LIQUID CHEMICAL STERILANT/HIGH-LEVEL DISINFECTANTMay 27, 2003
K030488FLUORILAQMay 2, 2003
K912632OCCLUDEJan 17, 1992
K911259HYDENTJun 6, 1991

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.