# K990020: TE ME NA Loss of Resistance Syringe, 10CC

- Pathway: 510(k) (Traditional)
- Applicant: Te ME NA S.A.R.L.
- Decided: Jun 24, 1999 after 171 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
THE Loss oF NEsiSTAveE SYNWGE (S ZNTEMED To BE USED o THE pErFECTIOF AND ¢,/vp;¢,n47/o,¢ OF THE PLRACEMENT ok rHE EP1po FEoLe ZN7o THE EPIDvRAL SPREE Prlion 1o EFpRAL pugih&I18, AL po Forn THE Lo55 oF PESIS7AvEE TECHNIRVE owey THE SYQInEE | § ZrorENOEP Z7 /S NoT INFENOED Fon RSPIRATION &2 LNJECT 04/,

Source page: https://510kreport.com/device/K990020
Methodology: https://510kreport.com/methodology