# K060743: Modification to: Tamper Evident Ultrasafe Passive Delivery System, Ultrasafe Passive Delivery System (X-Series)

- Pathway: 510(k) (Traditional)
- Applicant: Safety Syringes, Inc.
- Decided: Apr 28, 2006 after 39 days
- Product code: MEG (Syringe, Antistick)
- 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.
9 later devices descend from it; 4 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Tamper Evident UltraSafe® Passive™ Delivery System: named in the summary without a submission number
- (no number) UltraSafe® Passive™ Delivery System (X-Series): named in the summary without a submission number

## Most influential descendants
- K101233: Safe'n'sound Passive Delivery System (2011), 5 descendants of its own
- K122558: Ultrasafe Passive Needle Guard (2012), 4 descendants of its own
- K123743: Ultrasafe Plus Passive Needle Guard (2013), 3 descendants of its own
- K141664: Safe'n'sound Staked Passive Delivery System - Cone Version (2014), 1 descendant of its own
- K141464: Novaguard S a Safety System (2014), 1 descendant of its own

## Indications for use
Single use devices that are indicated for use as an accessory with pre-filled ISO Standard glass syringes to aid in the protection of healthcare professionals, patients who self-inject doctor prescribed medications, and individuals that assist self-injecting patients, from accidental needlesticks The intended patient population is unrestricted and may include children and adults, and parenteral methods of administration. Single use devices that are indicated for use as an accessory with pre-filled ISO Standard glass syringes to bid in the protection of healthcare professionals, patients who self-inject doctor prescribed medications, and individuals that assist self-injecting patients, from accidental needlesticks. The intended patient population is unrestricted and may include children and adults, and parenteral methods of administration.

Source page: https://510kreport.com/device/K060743
Methodology: https://510kreport.com/methodology