# K012736: Monoject Safety Needle - Pathway: 510(k) (Traditional) - Applicant: Tyco Healthcare - Decided: Oct 25, 2001 after 70 days - Product code: FMI (Needle, Hypodermic, Single Lumen) - Device class: 2 - Regulation: 21 CFR 880.5570 - Recalls of this device: 93 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 1 generation back to K911037 (1991). 2 ancestors in all. 2 later devices descend from it; 2 cite it directly. 0 of 5 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K951254: Safetyglide Needle, Bd Becton Dickinson Vacutainer Systems Preanalytic (1995) Summary page 1. - K911037: Safety Needle Sheath, Modification, Concord/Portex (1991) Summary page 1. ## Most influential descendants - K253110: Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe (2026), 0 descendants of its own - K082908: Novaguard, Model 3611001 (2009), 0 descendants of its own ## Recalls of this device - Feb 9, 2021 · Class II · Z-1252-2021: Safety shield not locking into the cannula. If the safety shield activation fails to lock a contaminated needle, a needlestick may occur and there is the potential for exposure to bloodborne pathogens - Oct 26, 2007 · Not classified · Z-0730-2008: Incorrect Needle size - Some of the kits contain a 1 inch 21G needle instead of the 1-1/2 inch 21 needle specified on the kit label. - Oct 26, 2007 · Not classified · Z-0729-2008: Incorrect Needle size - Some of the kits contain a 1 inch 21G needle instead of the 1-1/2 inch 21G needle specified on the kit label. - Oct 8, 2004 · Not classified · Z-0151-05: Needle cannula may separate from the hub during use - Oct 8, 2004 · Not classified · Z-0138-05: Needle cannula may separate from the hub during use - Oct 8, 2004 · Not classified · Z-0092-05: Needle cannula may separate from the hub during use - Oct 8, 2004 · Not classified · Z-0100-05: Needle cannula may separate from the hub during use - Oct 8, 2004 · Not classified · Z-0080-05: Needle cannula may separate from the hub during use - Oct 8, 2004 · Not classified · Z-0107-05: Needle cannula may separate from the hub during use - Oct 8, 2004 · Not classified · Z-0073-05: Needle cannula may separate from the hub during use - Oct 8, 2004 · Not classified · Z-0095-05: Needle cannula may separate from the hub during use - Oct 8, 2004 · Not classified · Z-0134-05: Needle cannula may separate from the hub during use - Oct 8, 2004 · Not classified · Z-0076-05: Needle cannula may separate from the hub during use - Oct 8, 2004 · Not classified · Z-0143-05: Needle cannula may separate from the hub during use - Oct 8, 2004 · Not classified · Z-0097-05: Needle cannula may separate from the hub during use - Oct 8, 2004 · Not classified · Z-0070-05: Needle cannula may separate from the hub during use - Oct 8, 2004 · Not classified · Z-0101-05: Needle cannula may separate from the hub during use - Oct 8, 2004 · Not classified · Z-0090-05: Needle cannula may separate from the hub during use - Oct 8, 2004 · Not classified · Z-0079-05: Needle cannula may separate from the hub during use - Oct 8, 2004 · Not classified · Z-0094-05: Needle cannula may separate from the hub during use - Oct 8, 2004 · Not classified · Z-0111-05: Needle cannula may separate from the hub during use - Oct 8, 2004 · Not classified · Z-0084-05: Needle cannula may separate from the hub during use - Oct 8, 2004 · Not classified · Z-0112-05: Needle cannula may separate from the hub during use - Oct 8, 2004 · Not classified · Z-0117-05: Needle cannula may separate from the hub during use - Oct 8, 2004 · Not classified · Z-0113-05: Needle cannula may separate from the hub during use - Oct 8, 2004 · Not classified · Z-0121-05: Needle cannula may separate from the hub during use - Oct 8, 2004 · Not classified · Z-0132-05: Needle cannula may separate from the hub during use - Oct 8, 2004 · Not classified · Z-0071-05: Needle cannula may separate from the hub during use - Oct 8, 2004 · Not classified · Z-0136-05: Needle cannula may separate from the hub during use - Oct 8, 2004 · Not classified · Z-0091-05: Needle cannula may separate from the hub during use - Oct 8, 2004 · Not classified · Z-0140-05: Needle cannula may separate from the hub during use - Oct 8, 2004 · Not classified · Z-0081-05: Needle cannula may separate from the hub during use - Oct 8, 2004 · Not classified · Z-0145-05: Needle cannula may separate from the hub during use - Oct 8, 2004 · Not classified · Z-0077-05: Needle cannula may separate from the hub during use - Oct 8, 2004 · Not classified · Z-0066-05: Needle cannula may separate from the hub during use - Oct 8, 2004 · Not classified · Z-0098-05: Needle cannula may separate from the hub during use - Oct 8, 2004 · Not classified · Z-0072-05: Needle cannula may separate from the hub during use - Oct 8, 2004 · Not classified · Z-0099-05: Needle cannula may separate from the hub during use - Oct 8, 2004 · Not classified · Z-0085-05: Needle cannula may separate from the hub during use - Oct 8, 2004 · Not classified · Z-0104-05: Needle cannula may separate from the hub during use - Oct 8, 2004 · Not classified · Z-0069-05: Needle cannula may separate from the hub during use - Oct 8, 2004 · Not classified · Z-0068-05: Needle cannula may separate from the hub during use - Oct 8, 2004 · Not classified · Z-0075-05: Needle cannula may separate from the hub during use - Oct 8, 2004 · Not classified · Z-0110-05: Needle cannula may separate from the hub during use - Oct 8, 2004 · Not classified · Z-0064-05: Needle cannula may separate from the hub during use - Oct 8, 2004 · Not classified · Z-0123-05: Needle cannula may separate from the hub during use - Oct 8, 2004 · Not classified · Z-0125-05: Needle cannula may separate from the hub during use - Oct 8, 2004 · Not classified · Z-0106-05: Needle cannula may separate from the hub during use - Oct 8, 2004 · Not classified · Z-0065-05: Needle cannula may separate from the hub during use - Oct 8, 2004 · Not classified · Z-0074-05: Needle cannula may separate from the hub during use ## Indications for use The primary function of the device is to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The needle stick prevention feature of the device helps prevent accidental needle sticks by shielding the needle after use. Source page: https://510kreport.com/device/K012736 Methodology: https://510kreport.com/methodology