510(k) Report

510(k) · Cleared

Cleared

MDT Chemitest See-Thru Bag

K831425510(k) TraditionalCleared Jun 2, 198330-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

Kenpak Converters, Inc. · FRG Wrap, Sterilization

Cleared on Jun 2, 1983 after a 30-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided
Jun 2, 1983
Review
30 days
Class
Class II
Product code
FRG
Recalls
None
Predicates
0

3 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2015: 1 descendant cleared2020: 1 descendant cleared2017: 1 descendant cleared19801990200020102020
  1. This deviceK831425 MDT Chemitest See-Thru BagKenpak Converters, Inc. · 1983
  2. Descendant · cites it directly · 2 of its ownK152058 Tyvek Sterilization Pouches with Chevron SealAndersen Sterilizers, Inc. · 2015
  3. Descendant · 2 generations on · 0 of its ownK200336 Tyvek Sterilization Pouches with Chevron SealAndersen Sterilizers, Inc. · 2020
  4. Descendant · 2 generations on · 0 of its ownK170429 Tyvek Sterilization Pouches with Chevron SealAndersen Sterilizers, Inc. · 2017

Most influential descendants

Showing 3 of 3 · See all
  • K152058Tyvek Sterilization Pouches with Chevron SealAndersen Sterilizers, Inc. · 2015 · cites it directly2descendants
  • K200336Tyvek Sterilization Pouches with Chevron SealAndersen Sterilizers, Inc. · 2020 · 2 generations on0descendants
  • K170429Tyvek Sterilization Pouches with Chevron SealAndersen Sterilizers, Inc. · 2017 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K831425MDT Chemitest See-Thru BagKenpak Converters, Inc.1983—
+1K152058Tyvek Sterilization Pouches with Chevron SealAndersen Sterilizers, Inc.2015—
+2K200336Tyvek Sterilization Pouches with Chevron SealAndersen Sterilizers, Inc.2020—
+2K170429Tyvek Sterilization Pouches with Chevron SealAndersen Sterilizers, Inc.2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201710
202010
FIG. 1 — Lineage of K831425, 1983–2020Source: 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), 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K152058Tyvek Sterilization Pouches with Chevron SealAndersen Sterilizers, Inc.20152

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?

  • Of its descendants, K152058 (Andersen Sterilizers, Inc., 2015) has gone furthest, with 2 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.

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—

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/K831425 · printed Nov 6, 2026

Cite this page

510(k) Report. “K831425: MDT Chemitest See-Thru Bag.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K831425

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026