510(k) Report

510(k) · Cleared

Cleared

Turbett Instrument Pod

K202593510(k) TraditionalCleared May 19, 2021253-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

Turbett Surgical, Inc. · FRG Wrap, Sterilization

Cleared on May 19, 2021 as substantially equivalent to K200240 (Turbett Surgical, Inc., 2020) after a 253-day review. Its family tree reaches back 3 generations to 2012. 1 later device descends from it.

Decided
May 19, 2021
Review
253 days
Class
Class II
Product code
FRG
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K110898 (2012). 1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2025: 1 descendant clearedK110898 · S.C.O.R.E.S. Unit · Ammed Surgical Equipment, LLC · 2012 · recalledK153025 · Turbett Surgical Container · Turbett Surgical, LLC · 2016 · recalledK200240 · Turbett Instrument Pod · Turbett Surgical, Inc. · 20202010201520202025
Descendants, by generation 1 generation forward: 1 descendant K200240 · Turbett Instrument Pod · Turbett Surgical, Inc. · 2020K153025 · Turbett Surgical Container · Turbett Surgical, LLC · 2016 · recalledK110898 · S.C.O.R.E.S. Unit · Ammed Surgical Equipment, LLC · 2012 · recalled0
  1. Root · 3 generations backK110898 S.C.O.R.E.S. UnitAmmed Surgical Equipment, LLC · 2012 · Recalled
  2. 2 generations backK153025 Turbett Surgical ContainerTurbett Surgical, LLC · 2016 · Recalled
  3. 1 generation backK200240 Turbett Instrument PodTurbett Surgical, Inc. · 2020
  4. This deviceK202593 Turbett Instrument PodTurbett Surgical, Inc. · 2021
  5. Descendant · cites it directly · 0 of its ownK250011 Turbett Surgical Instrument Pod (TS1500); Turbett Surgical…Turbett Surgical · 2025

Most influential descendants

Showing 1 of 1 · See all
  • K250011Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200)…Turbett Surgical · 2025 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K110898S.C.O.R.E.S. UnitAmmed Surgical Equipment, LLC20121
−2K153025Turbett Surgical ContainerTurbett Surgical, LLC20164
−1K200240Turbett Instrument PodTurbett Surgical, Inc.2020—
0 (this device)K202593Turbett Instrument PodTurbett Surgical, Inc.2021—
+1K250011Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod…Turbett Surgical2025—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202510
FIG. 1 — Lineage of K202593, 2012–2025Source: 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 FRG? 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 FRG device

  1. #1 K234050 HALYARD® ONE-STEP® Sterilization Wrap…score 15.8 · 7 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? (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
*K200240Turbett Instrument Pod
Summary page 4
…0.6850) 4. Common/Classification Name: Sterilization wrap/container; Predicate device - Turbett Surgical Container K200240 Description: The Turbett Instrument Pod is a rigid sterilization container with a fenestrated door holding a si…
Turbett Surgical, Inc.2020—

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K250011Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200)…Turbett Surgical20250

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 9 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
  • 2 of the 3 ancestors have a recall of any class.
  • Of its descendants, K250011 (Turbett Surgical, 2025) has gone furthest, with 0 descendants of its own.

How does its category compare?

All FRG devices

FRG Wrap, Sterilization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.

FDA decisions per year · FRG

9in 2025

2007: 32008: 22009: 42010: 42011: 62012: 102013: 62014: 82015: 122016: 92017: 92018: 52019: 92020: 52021: 42022: 92023: 92024: 112025: 92026 (partial year): 4
2007high 12 (2015) · low 2 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FRG

151in 2025

2007: 182 days median2009: 171 days median2010: 213 days median2011: 110 days median2012: 133 days median2013: 146 days median2014: 177 days median2015: 196 days median2016: 131 days median2017: 260 days median2018: 150 days median2019: 258 days median2020: 122 days median2021: 170 days median2022: 217 days median2023: 230 days median2024: 182 days median2025: 151 days median2026 (partial year): 247 days median
2007high 260 (2017) · low 110 (2011)2026

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

Recalls per year · FRG

2in 2022

2013: 22017: 292020: 142022: 2
2007high 29 (2017) · low 0 (2007)2026

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

Adverse event reports per year · FRG

18in 2025

2007: 12008: 22009: 22011: 122012: 42013: 52014: 132015: 92016: 202017: 72018: 222019: 102020: 212021: 92022: 42023: 132024: 212025: 18
2007high 22 (2018) · low 0 (2010)2025

MAUDE reports naming product code FRG, 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
2007318201
20082—02
2009417102
2010421300
20116110012
20121013304
2013614625
20148177013
20151219609
20169131020
20179260297
20185150022
20199258010
202051221421
2021417009
2022921724
20239230013
202411182021
20259151018
202642470—

What is it indicated for?

The Turbett Instrument Pod is indicated for enclosing other medical devices that are to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed materials and maintain sterility for up to 30 days until used. The unit is intended to be used in pre-vacuum steam sterilizers. The unit must be used with the Turbett Surgical filters. The unit is intended to be used in prevacuum steam sterilizers with a prevacuum cycle of…

Read the full statement (208 words)

The Turbett Instrument Pod is indicated for enclosing other medical devices that are to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed materials and maintain sterility for up to 30 days until used. The unit is intended to be used in pre-vacuum steam sterilizers. The unit must be used with the Turbett Surgical filters.

The unit is intended to be used in prevacuum steam sterilizers with a prevacuum cycle of 270F (132C) and exposure time of 4 minutes.

* The TS1500 Container may be loaded to a maximum weight of 375 Ibs., not to exceed 25 Ibs. in any tray. Minimum drying time for loads up to 140 Ibs. is 10 minutes, for loads up to 375 lbs. 30 minutes.

* The TS1200 Container may be loaded to a maximum weight of 120 Ibs., not to exceed 25 Ibs. in any tray. Minimum drying time is 10 minutes.

* The TS1000 Container may be loaded to a maximum weight of 100 Ibs., not to exceed 25 Ibs. in any tray. Minimum drying time is 10 minutes.

» The system was validated with Imm x 500mm lumens.

Use only uncovered, perforated or wire mesh general delivery trays within the Turbett Instrument Pod.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Turbett Surgical, Inc.

2 FDA decisions under this applicant name. See the company

  • K200240Turbett Instrument PodTurbett Surgical, Inc. · 2020

Recent decisions in FRG

The FRG category page

  • K261897HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap…O&M Halyard, Inc. · 2026
  • K252823Dukal Crepe Paper Sterilization WrapDukal, LLC · 2026
  • K253454HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL…O&M Halyard, Inc. · 2026
  • K251347Sterilization Pouch/RollSterivic Medical Co., Ltd. · 2026
  • K251177Self-Seal Sterilization Pouch and RollGuangdong Maidi Medical Co., Ltd. · 2025

https://510kreport.com/device/K202593 · printed Nov 6, 2026

Cite this page

510(k) Report. “K202593: Turbett Instrument Pod.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202593

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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