510(k) Report

510(k) · Cleared

Cleared

Paragon Medical Surgical Instrument Delivery System Various

K032119510(k) TraditionalCleared Oct 29, 2003112-day reviewClass II21 CFR 880.6850

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Paragon Medical, Inc. · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Cleared on Oct 29, 2003 as substantially equivalent to K012105 (Symmetry Medical, Inc., 2002) and 1 other predicate after a 112-day review. Its family tree reaches back 4 generations to 1984. 18 later devices descend from it.

Decided
Oct 29, 2003
Review
112 days
Class
Class II
Product code
KCT
Recalls
None
Predicates
2

Its longest line of descent runs back 4 generations to K844002 (1984). 7 ancestors in all. 18 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor1994: 1 other ancestor1997: 1 other ancestor2010: 2 descendants cleared2018: 1 descendant cleared2008: 1 descendant cleared2019: 1 descendant cleared2013: 1 descendant cleared2025: 3 descendants cleared2021: 2 descendants cleared2022: 1 descendant cleared2023: 1 descendant cleared2020: 2 descendants cleared2024: 2 descendants cleared2026: 1 descendant clearedK844002 · HU-Friedy Ims Cassette System · Hu-Friedy Mfg. Co., Inc. · 1984K980065 · C/T Med-Systems Cassette System · C/T Med System, Ltd. · 1998K990761 · Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette · Tuttnauer U.S.A Co, Ltd. · 1999K012105 · Polyvac Surgical Instrument Delivery System · Symmetry Medical, Inc. · 200219801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor3 generations back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 6 descendants3 generations forward: 3 descendants4 generations forward: 2 descendants5 generations forward: 2 descendants6 generations forward: 1 descendant K012105 · Polyvac Surgical Instrument Delivery System · Symmetry Medical, Inc. · 2002K990761 · Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette · Tuttnauer U.S.A Co, Ltd. · 1999K980065 · C/T Med-Systems Cassette System · C/T Med System, Ltd. · 1998K844002 · HU-Friedy Ims Cassette System · Hu-Friedy Mfg. Co., Inc. · 19840+5
  1. Root · 4 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
  2. 3 generations backK980065 C/T Med-Systems Cassette SystemC/T Med System, Ltd. · 1998
  3. 2 generations backK990761 Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteTuttnauer U.S.A Co, Ltd. · 1999
  4. 1 generation backK012105 Polyvac Surgical Instrument Delivery SystemSymmetry Medical, Inc. · 2002
  5. This deviceK032119 Paragon Medical Surgical Instrument Delivery System VariousParagon Medical, Inc. · 2003
  6. Descendant · cites it directly · 7 of its ownK072211 Intuitive Surgical Instrument and Accessories Sterilization TraysIntuitive Surgical, Inc. · 2008
  7. Descendant · 2 generations on · 6 of its ownK180127 TCAT (R) THA Instrument Tray SetTHINK Surgical, Inc. · 2019
  8. Descendant · cites it directly · 6 of its ownK181819 SMARTRELEASE Endoscopic Soft Tissue Release SystemMicroaire Surgical Instruments, LLC · 2018
  9. Descendant · 3 generations on · 5 of its ownK200632 TCAT TKA Instrument Tray SetTHINK Surgical, Inc. · 2020
  10. Descendant · 4 generations on · 3 of its ownK202268 CrossRoads Tray SystemCrossroads Extremity Systems, LLC · 2020

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

2008: 12010: 22013: 12018: 12019: 12020: 22021: 22022: 12023: 12024: 22025: 32026: 1
2008high 3 (2025) · low 0 (2009)2026

Most influential descendants

Showing 5 of 18 · See all
  • K072211Intuitive Surgical Instrument and Accessories Sterilization TraysIntuitive Surgical, Inc. · 2008 · cites it directly7descendants
  • K180127TCAT (R) THA Instrument Tray SetTHINK Surgical, Inc. · 2019 · 2 generations on6descendants
  • K181819SMARTRELEASE Endoscopic Soft Tissue Release SystemMicroaire Surgical Instruments, LLC · 2018 · cites it directly6descendants
  • K200632TCAT TKA Instrument Tray SetTHINK Surgical, Inc. · 2020 · 3 generations on5descendants
  • K202268CrossRoads Tray SystemCrossroads Extremity Systems, LLC · 2020 · 4 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K844002HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc.1984—
−3K980065C/T Med-Systems Cassette SystemC/T Med System, Ltd.1998—
−2K990761Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteTuttnauer U.S.A Co, Ltd.1999—
−1K012105Polyvac Surgical Instrument Delivery SystemSymmetry Medical, Inc.2002—
0 (this device)K032119Paragon Medical Surgical Instrument Delivery System VariousParagon Medical, Inc.2003—
+1K072211Intuitive Surgical Instrument and Accessories Sterilization TraysIntuitive Surgical, Inc.2008—
+2K180127TCAT (R) THA Instrument Tray SetTHINK Surgical, Inc.2019—
+1K181819SMARTRELEASE Endoscopic Soft Tissue Release SystemMicroaire Surgical Instruments, LLC2018—
+3K200632TCAT TKA Instrument Tray SetTHINK Surgical, Inc.2020—
+4K202268CrossRoads Tray SystemCrossroads Extremity Systems, LLC2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199710
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201020
201310
201810
201910
202020
202120
202210
202310
202420
202530
202610
FIG. 1 — Lineage of K032119, 1984–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KCT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new KCT device

  1. #1 K214041 Aesculap AICON Containerscore 18.1 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K012105Polyvac Surgical Instrument Delivery System
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”.
Symmetry Medical, Inc.2002—
*K993535Metapak Multi-Purpose Instrument Tray
Summary page 2
…Instrument Delivery System manufactured by Symmetry Medical, Inc. (# K102105), and that of MetaPak Multi Purpose Instrument Tray, manufactured by Riley Medical, Tnc. (# K993535) Performance Testing: The Surgical Instrument Delivery System has been validated to perforin effectively during steam steriliza…
Riley Medical, Inc.2001—

Also cleared against K012105: 20 other devices →

What descends from it? (18)

See all 18

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K072211Intuitive Surgical Instrument and Accessories Sterilization TraysIntuitive Surgical, Inc.20087
K181819SMARTRELEASE Endoscopic Soft Tissue Release SystemMicroaire Surgical Instruments, LLC20186
K092414Conmed Detachatip Instrument Tray, 33CM and 43CMConmed Corporation20101
K100887Versitomic Acl Flexible Reamer System Sterilization TrayTag Medical Products20100

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.

What does this lineage say?

  • The line of descent spans 19 years and passes through 5 companies; a new generation was cleared every 3.1 years on median.
  • None of the 7 ancestors has a recall.
  • Of its descendants, K072211 (Intuitive Surgical, Inc., 2008) has gone furthest, with 7 descendants of its own.
  • 20 other devices also cite its predicate K012105.

How does its category compare?

All KCT devices

KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KCT

11in 2025

2007: 32008: 62009: 62010: 122011: 62012: 102013: 82014: 112015: 152016: 122017: 102018: 152019: 182020: 142021: 182022: 112023: 102024: 82025: 112026 (partial year): 9
2007high 18 (2019) · low 3 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KCT

205in 2025

2007: 199 days median2008: 182 days median2009: 89 days median2010: 202 days median2011: 117 days median2012: 236 days median2013: 131 days median2014: 169 days median2015: 151 days median2016: 182 days median2017: 211 days median2018: 192 days median2019: 187 days median2020: 134 days median2021: 185 days median2022: 137 days median2023: 94 days median2024: 106 days median2025: 205 days median2026 (partial year): 122 days median
2007high 236 (2012) · low 89 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KCT

17in 2022

2010: 12011: 22013: 12014: 12016: 32017: 12021: 12022: 17
2007high 17 (2022) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KCT

50in 2025

2007: 22008: 82009: 52010: 32011: 32012: 22013: 62014: 52015: 62016: 162017: 32018: 222019: 152020: 662021: 262022: 82023: 302024: 182025: 50
2007high 66 (2020) · low 2 (2007)2025

MAUDE reports naming product code KCT, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007319902
2008618208
200968905
20101220213
2011611723
20121023602
2013813116
20141116915
20151515106
201612182316
20171021113
201815192022
201918187015
202014134066
202118185126
202211137178
20231094030
20248106018
202511205050
202691220—

What is it indicated for?

used with an approved sterilization wrap.

Sterilization Cycle: Prevacuum. 132°C for 4 minutes

Indications for use as stated in the FDA summary.

Also cleared against K012105

20 other devices cite the same predicate.

  • K242023Microdent Sterilization CassetteImplant Microdent System S.L.U. · 2025
  • K203198KARL STORZ Metal Sterilization TraysKarl Storz Endoscopy America, Inc. · 20211 recall
  • K203572Karl Storz Radel Sterilization TraysKarl Storz Endoscopy America, Inc. · 20211 recall
  • K201945KARL STORZ UDEL Sterilization TraysKarl Storz Endoscopy America, Inc. · 20211 recall
  • K162063Steri-Cassette and Steri-Cage Sterilization Packaging SystemSybron Dental Specialties · 2017
  • K152745ReNew Sterilization Trays (Catalog #3708 and #3709)Microline Surgical, Inc. · 2016

More from Paragon Medical, Inc.

2 FDA decisions under this applicant name. See the company

  • K152951Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, Camera…Paragon Medical, Inc. · 2015

Recent decisions in KCT

The KCT category page

  • K262084S.I.N. Instruments KitsS.I.N. Implant System Ltda · 2026
  • K262042Sterilization Cassette (CASS-1)Alliedstar Medical Equipment Co., Ltd. · 2026
  • K253988LiteSet TraysNobel Biocare AB · 2026
  • K261935Surgical and Prosthetic TraysDentsply Sirona, Inc. · 2026
  • K253187SteriBest® Sterilization Tray SystemMastel Surgical · 2026

https://510kreport.com/device/K032119 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032119: Paragon Medical Surgical Instrument Delivery System Various.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032119

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026