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
| Records | Count | Last refreshed | Source as of | Status |
| Recalls | 0 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 8 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 6 | Nov 10, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
| Aug 21, 2025 | Bellevue, WA | Devices | No Action Indicated (NAI) | 3011632 |
| Mar 5, 2018 | Bellevue, WA | Devices | No Action Indicated (NAI) | 3011632 |
| Aug 31, 2016 | Bellevue, WA | Devices | No Action Indicated (NAI) | 3011632 |
| Feb 25, 2013 | Bellevue, WA | Devices | No Action Indicated (NAI) | 3011632 |
| Aug 3, 2011 | Bellevue, WA | Drugs | No Action Indicated (NAI) | 3011632 |
| Apr 21, 2011 | Bellevue, WA | Devices | No 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
| Facility | Location | Inspections | Latest |
| FEI 3011632 | Bellevue, WA | 6 | Aug 21, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
| K102526 | BLO2X OXYGEN BLOCKER | Oct 22, 2010 |
| K090597 | FLUORILAQ SODIUM FLUORIDE CAVITY VARNISH | Mar 16, 2009 |
| K040988 | ZIRCON-F PROPHYLAXIS PASTE | Jul 7, 2004 |
| K040661 | RADENT PROPHY PASTE | Jun 9, 2004 |
| K012889 | BANICIDE LIQUID CHEMICAL STERILANT/HIGH-LEVEL DISINFECTANT | May 27, 2003 |
| K030488 | FLUORILAQ | May 2, 2003 |
| K912632 | OCCLUDE | Jan 17, 1992 |
| K911259 | HYDENT | Jun 6, 1991 |