Integrated Sensing Systems, Inc. FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

  • No warning letters matched by name
Inspections 0 0 OAI
Recalls 0 0 Class I
Warning letters 0 None on file
510(k) clearances 1 Latest Feb 22, 2006

Integrated Sensing Systems, Inc. has 0 FDA recalls, 0 inspections, 1 510(k) clearance and 0 compliance actions on record. No FDA warning letter addressed to "Integrated Sensing Systems, Inc." is on file.

What these totals cover: FDA records filed under the name "Integrated Sensing Systems, Inc." and its spelling variant "Integrated Sensing Systems".

Latest 510(k)
Feb 22, 2006

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 11, 2026 (checked Nov 15, 2026, unchanged)File dated Nov 10, 2026Current
510(k) clearances1Nov 15, 2026File dated Nov 9, 2026Current
Inspections0Nov 15, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

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Recent 510(k) clearances

1 510(k) clearance on Feb 22, 2006.

K-NumberDeviceDate
K050783ISSYS DRUG FLOW MONITORFeb 22, 2006

Integrated Sensing Systems, Inc. and the FDA: common questions

Has Integrated Sensing Systems, Inc. received an FDA warning letter?

No FDA warning letter addressed to the name "Integrated Sensing Systems, Inc." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Integrated Sensing Systems, Inc. received an FDA Form 483?

FDA has not published a Form 483 for "Integrated Sensing Systems, Inc." in its reading room. FDA publishes some Form 483s, not all of them.

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