510(k) Report

510(k) · Cleared

Cleared

Versapod (TM) Instrument Trays

K071783510(k) TraditionalCleared Sep 9, 2008435-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

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

Cleared on Sep 9, 2008 as substantially equivalent to K012105 (Symmetry Medical, Inc., 2002) after a 435-day review. Its family tree reaches back 4 generations to 1984. 3 later devices descend from it.

Decided
Sep 9, 2008
Review
435 days
Class
Class II
Product code
KCT
Recalls
None
Predicates
1

Its longest line of descent runs back 4 generations to K844002 (1984). 6 ancestors in all. 3 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1994: 1 other ancestor1997: 1 other ancestor2016: 1 descendant cleared2010: 1 descendant cleared2017: 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 2 generations back: 1 other ancestor3 generations back: 1 other ancestor 1 generation forward: 2 descendants2 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
  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 deviceK071783 Versapod (TM) Instrument TraysContainmed, Inc. · 2008
  6. Descendant · cites it directly · 1 of its ownK151594 Ellipse Supplemental Instrument TraysEllipse Technologies, Incorporated · 2016
  7. Descendant · 2 generations on · 0 of its ownK170939 Supplemental Instrument TraysNuvasive Specialized Orthopedics, Incorporated · 2017
  8. Descendant · cites it directly · 0 of its ownK093800 Robinson Medsurg Quickscrew RackRobinson Medsurg, LLC · 2010

Most influential descendants

Showing 3 of 3 · See all
  • K151594Ellipse Supplemental Instrument TraysEllipse Technologies, Incorporated · 2016 · cites it directly1descendant
  • K170939Supplemental Instrument TraysNuvasive Specialized Orthopedics, Incorporated · 2017 · 2 generations on0descendants
  • K093800Robinson Medsurg Quickscrew RackRobinson Medsurg, LLC · 2010 · cites it directly0descendants
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)K071783Versapod (TM) Instrument TraysContainmed, Inc.2008—
+1K151594Ellipse Supplemental Instrument TraysEllipse Technologies, Incorporated2016—
+2K170939Supplemental Instrument TraysNuvasive Specialized Orthopedics, Incorporated2017—
+1K093800Robinson Medsurg Quickscrew RackRobinson Medsurg, LLC2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201610
201710
FIG. 1 — Lineage of K071783, 1984–2017Source: 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
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What was it cleared against? (1)

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
Summary page 1
…rays Device Class: II Classification Name: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (CFR 880.6850, Product Code KCT) Predicate Device: K012105-Poly Vac Surgical Instrument Delivery System Device Description: ContainMed VersaPodTM Instrument Trays consist of an anodized…
Symmetry Medical, Inc.2002—

Also cleared against K012105: 20 other devices →

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K151594Ellipse Supplemental Instrument TraysEllipse Technologies, Incorporated20161
K093800Robinson Medsurg Quickscrew RackRobinson Medsurg, LLC20100

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 24 years and passes through 5 companies; a new generation was cleared every 6.1 years on median.
  • None of the 6 ancestors has a recall.
  • Of its descendants, K151594 (Ellipse Technologies, Incorporated, 2016) has gone furthest, with 1 descendant 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. 2008, this device’s year, is highlighted.

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?

ContainMed, Inc. VersaPodTM Instrument Trays organize, protect, and transport medical instruments during prevacuum steam sterilization and subsequent storage. They do not maintain sterility unless used in conjunction with an FDA-cleared and legally marketed sterilization wrap. This device has not been validated for sterilization of instruments that are porous or have lumens.

Prevacuum Steam Cycle Parameters: 1320 C, 4 minutes

Drying: 45 minutes

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K071783: Versapod (TM) Instrument Trays.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071783

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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