# K032119: Paragon Medical Surgical Instrument Delivery System Various

- Pathway: 510(k) (Traditional)
- Applicant: Paragon Medical, Inc.
- Decided: Oct 29, 2003 after 112 days
- Product code: KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories)
- Device class: 2
- Regulation: 21 CFR 880.6850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K844002 (1984). 7 ancestors in all.
18 later devices descend from it; 4 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012105: Polyvac Surgical Instrument Delivery System, Symmetry Medical, Inc. (2002). Our reading of the summary gave K102105, which is not a number in FDA’s lists. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “PolyVac Surgical Instrument Delivery System”.
- K993535: Metapak Multi-Purpose Instrument Tray, Riley Medical, Inc. (2001) Summary page 2.

## Most influential descendants
- K072211: Intuitive Surgical Instrument and Accessories Sterilization Trays (2008), 7 descendants of its own
- K180127: TCAT (R) THA Instrument Tray Set (2019), 6 descendants of its own
- K181819: SMARTRELEASE Endoscopic Soft Tissue Release System (2018), 6 descendants of its own
- K200632: TCAT TKA Instrument Tray Set (2020), 5 descendants of its own
- K202268: CrossRoads Tray System (2020), 3 descendants of its own

## Indications for use
used with an approved sterilization wrap. Sterilization Cycle: Prevacuum. 132°C for 4 minutes

Source page: https://510kreport.com/device/K032119
Methodology: https://510kreport.com/methodology