510(k) Report

510(k) · Cleared

Cleared

Ati Disposable Biological-Plus Test Pack

K925496510(k) TraditionalCleared Feb 1, 1994459-day reviewClass II21 CFR 880.2800

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

Pymah Corp. · FRC Indicator, Biological Sterilization Process

Cleared on Feb 1, 1994 after a 459-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 14 later devices descend from it.

Decided
Feb 1, 1994
Review
459 days
Class
Class II
Product code
FRC
Recalls
None
Predicates
0

14 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2010: 1 descendant cleared2013: 1 descendant cleared2018: 4 descendants cleared2017: 1 descendant cleared2020: 4 descendants cleared2022: 1 descendant cleared2024: 2 descendants cleared1990200020102020
  1. This deviceK925496 Ati Disposable Biological-Plus Test PackPymah Corp. · 1994
  2. Descendant · cites it directly · 11 of its ownK121593 3M Attest (TM) Super Radid Readout Steam Challenge Pack 3M Attest…3M Company · 2013
  3. Descendant · 2 generations on · 7 of its ownK173519 3M Attest Super Rapid Readout Steam Challenge Pack, 3M Attest Super…3M Company · 2018 · Recalled
  4. Descendant · 3 generations on · 3 of its ownK193154 3M Attest Super Rapid 5 Steam-Plus Challenge Pack3M Company · 2020 · Recalled
  5. Descendant · 3 generations on · 2 of its ownK192550 3MTM AttestTM Super Rapid Steam Biological Indicator 1592, 3MTM…3M Company · 2020
  6. Descendant · 4 generations on · 1 of its ownK213809 3M Attest Super Rapid Steam Biological Indicator, 3M Attest Super…3M Company · 2022

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2010: 12013: 12017: 12018: 42020: 42022: 12024: 2
2010high 4 (2018) · low 0 (2011)2026

Most influential descendants

Showing 5 of 14 · See all
  • K1215933M Attest (TM) Super Radid Readout Steam Challenge Pack 3M Attest (TM) Super Rapid 5…3M Company · 2013 · cites it directly11descendants
  • K1735193M Attest Super Rapid Readout Steam Challenge Pack, 3M Attest Super Rapid 5 Steam-Plus…3M Company · 2018 · 2 generations on7descendants
  • K1931543M Attest Super Rapid 5 Steam-Plus Challenge Pack3M Company · 2020 · 3 generations on3descendants
  • K1925503MTM AttestTM Super Rapid Steam Biological Indicator 1592, 3MTM AttestTM Super Rapid…3M Company · 2020 · 3 generations on2descendants
  • K2138093M Attest Super Rapid Steam Biological Indicator, 3M Attest Super Rapid Steam Challenge…3M Company · 2022 · 4 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K925496Ati Disposable Biological-Plus Test PackPymah Corp.1994—
+1K1215933M Attest (TM) Super Radid Readout Steam Challenge Pack 3M Attest (TM) Super…3M Company2013—
+2K1735193M Attest Super Rapid Readout Steam Challenge Pack, 3M Attest Super Rapid 5…3M Company20181
+3K1931543M Attest Super Rapid 5 Steam-Plus Challenge Pack3M Company20202
+3K1925503MTM AttestTM Super Rapid Steam Biological Indicator 1592, 3MTM AttestTM Super…3M Company2020—
+4K2138093M Attest Super Rapid Steam Biological Indicator, 3M Attest Super Rapid Steam…3M Company2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201310
201710
201840
202040
202210
202420
FIG. 1 — Lineage of K925496, 1994–2024Source: 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 FRC? 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 FRC device

  1. #1 K250044 Celerity 5 HP Biological Indicator (LCB052)…score 14.5 · 10 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (14)

See all 14

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

NumberDeviceApplicantDecidedDescendants
K1215933M Attest (TM) Super Radid Readout Steam Challenge Pack 3M Attest (TM) Super Rapid 5…3M Company201311
K1019103M Attest Rapid Readout Steam Process Challenge Device, Model 1296V, 3M Attest Rapid…3M Company20101

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, K121593 (3M Company, 2013) has gone furthest, with 11 descendants of its own.

How does its category compare?

All FRC devices

FRC Indicator, Biological Sterilization Process: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FRC

6in 2025

2007: 32008: 12009: 62010: 42011: 62012: 92013: 42014: 132015: 32016: 22017: 102018: 182019: 52020: 102021: 52022: 52023: 62024: 82025: 62026 (partial year): 1
2007high 18 (2018) · low 1 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FRC

29in 2025

2007: 83 days median2009: 183 days median2010: 165 days median2011: 118 days median2012: 178 days median2013: 260 days median2014: 174 days median2015: 130 days median2017: 130 days median2018: 97 days median2019: 88 days median2020: 150 days median2021: 107 days median2022: 193 days median2023: 190 days median2024: 105 days median2025: 29 days median
2007high 260 (2013) · low 29 (2025)2026

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

Recalls per year · FRC

8so far in 2026, the most since 2007

2009: 12012: 22013: 22022: 42023: 12026 (partial year): 8
2007high 8 (2026) · low 0 (2007)2026

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

Adverse event reports per year · FRC

9in 2025

2007: 1002008: 602009: 452010: 572011: 372012: 462013: 392014: 512015: 1822016: 4822017: 1822018: 222019: 302020: 162021: 102022: 92023: 202024: 222025: 9
2007high 482 (2016) · low 9 (2022)2025

MAUDE reports naming product code FRC, 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
20073830100
20081—060
20096183145
20104165057
20116118037
20129178246
20134260239
201413174051
201531300182
20162—0482
2017101300182
20181897022
2019588030
202010150016
20215107010
2022519349
20236190120
20248105022
202562909
20261—8—

More from Pymah Corp.

17 FDA decisions under this applicant name. See the company

  • K952995Ati Ethylene Oxide Sterilization IndicatorPymah Corp. · 1996
  • K952408Ati Disposable Test Pack for Steam SterilizationPymah Corp. · 1995
  • K951063Ati Disposable Test Pack for EO Gas SterilizationPymah Corp. · 1995
  • K934874Sterigage EO 100%Pymah Corp. · 1995
  • K943081Trimline 2000Pymah Corp. · 1995

Recent decisions in FRC

The FRC category page

  • K260766Celerity 5 HP Biological Indicator (LCB052)STERIS Corporation · 2026
  • K252680Celerity™ 20 HP Biological IndicatorSTERIS Corporation · 2025
  • K251122Terragene® Bionova® BT20 Biological IndicatorTerragene · 2025
  • K251452Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP…Steris · 2025
  • K250044Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP…STERIS Corporation · 2025

https://510kreport.com/device/K925496 · printed Nov 6, 2026

Cite this page

510(k) Report. “K925496: Ati Disposable Biological-Plus Test Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K925496

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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