510(k) · Cleared
ClearedNortec Ster Saline-O.9% Sodium Chlor for Dev Irri
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
North American Sterilization & Packaging Co. · LDQ (no longer in FDA’s product-code list)
Cleared on Dec 3, 1993 after a 393-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
- Decided
- Dec 3, 1993
- Review
- 393 days
- Product code
- LDQ
- Recalls
- None
- Predicates
- 0
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LDQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
https://510kreport.com/device/K925588 · printed Nov 4, 2026
Cite this page
510(k) Report. “K925588: Nortec Ster Saline-O.9% Sodium Chlor for Dev Irri.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K925588
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026