510(k) · Cleared

Recalled · 2006

3M Comply 1248 Gas Plasma Chemical Indicator

K013228510(k) TraditionalCleared Jan 18, 2002113-day reviewClass II21 CFR 880.2800Recalls 1

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

Minnesota Mining and Mfg. Co. · JOJ Indicator, Physical/Chemical Sterilization Process

Cleared on Jan 18, 2002 as substantially equivalent to K921910 (Johnson & Johnson Medical, Inc., 1993) after a 113-day review. Its family tree reaches back 1 generation to 1993. 14 later devices descend from it. It has been recalled once.

Decided: Jan 18, 2002
Review: 113 days
Class: Class II
Product code: JOJ
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K921910 (1993). 14 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK921910 Sterrad Chemical IndicatorJohnson & Johnson Medical, Inc. · 1993
This deviceK013228 3M Comply 1248 Gas Plasma Chemical IndicatorMinnesota Mining and Mfg. Co. · 2002
Descendant · cites it directly · 13 of its ownK150622 3M Comply Hydrogen Peroxide Chemical Indicator 12483M Company · 2015
Descendant · 2 generations on · 12 of its ownK170321 3M Comply Hydrogen Peroxide Chemical Indicator 12483M Company · 2017
Descendant · 3 generations on · 11 of its ownK183211 3M Comply Hydrogen Peroxide Chemical Indicator3M Company · 2019
Descendant · 4 generations on · 7 of its ownK193110 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator…3M Healthcare · 2020 · Recalled
Descendant · 5 generations on · 6 of its ownK203284 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator3M Company · 2020

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2015high 3 (2020) · low 0 (2016)2026

Most influential descendants

Showing 5 of 14 · See all

K1506223M Comply Hydrogen Peroxide Chemical Indicator 12483M Company · 2015 · cites it directly13descendants
K1703213M Comply Hydrogen Peroxide Chemical Indicator 12483M Company · 2017 · 2 generations on12descendants
K1832113M Comply Hydrogen Peroxide Chemical Indicator3M Company · 2019 · 3 generations on11descendants
K1931103M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E3M Healthcare · 2020 · 4 generations on7descendants
K2032843M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator3M Company · 2020 · 5 generations on6descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K921910	Sterrad Chemical Indicator	Johnson & Johnson Medical, Inc.	1993	—
0 (this device)	K013228	3M Comply 1248 Gas Plasma Chemical Indicator	Minnesota Mining and Mfg. Co.	2002	—
+1	K150622	3M Comply Hydrogen Peroxide Chemical Indicator 1248	3M Company	2015	—
+2	K170321	3M Comply Hydrogen Peroxide Chemical Indicator 1248	3M Company	2017	—
+3	K183211	3M Comply Hydrogen Peroxide Chemical Indicator	3M Company	2019	—
+4	K193110	3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E	3M Healthcare	2020	1
+5	K203284	3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator	3M Company	2020	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2015	1	0
2017	1	0
2019	2	0
2020	3	0
2022	3	0
2023	1	0
2024	3	0

FIG. 1 — Lineage of K013228, 1993–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 JOJ? 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 JOJ device

#1 K261992 3M™ Attest™ Steam Chemical Integrator (1243A…score 13.3 · 5 generations · no Class I recall
#2 Held for the reportin the report
#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.

Type	Number	Device	Applicant	Decided	Recalls
*	K921910	Sterrad Chemical Indicator Summary page 1 …3M Comply 1248 Gas Plasma Chemical Indicator Strip is substantially equivalent to the Advanced Sterilization Products (ASP) STERRAD® Gas Plasma Chemical Indicator Strip (K921910). The 3M Comply 1248 Gas Plasma Chemical Indicator and the predicate device share the same intended use of internal pack steriliz…	Johnson & Johnson Medical, Inc.	1993	—

Also cleared against K921910: 4 other devices →

What descends from it? (14)

See all 14

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

Number	Device	Applicant	Decided	Descendants
K150622	3M Comply Hydrogen Peroxide Chemical Indicator 1248	3M Company	2015	13

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 9, 2006	Not classified	Z-0027-2007	Other	3M Comply 1248 Gas Plasma Chemical Indicator Strips were manufactured with a material that may cause some of the indicators to show an inaccurate result if not read immediately after processing.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K150622 (3M Company, 2015) has gone furthest, with 13 descendants of its own.
4 other devices also cite its predicate K921910.

How does its category compare?

All JOJ devices

JOJ Indicator, Physical/Chemical Sterilization Process: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JOJ

6in 2025

2007high 13 (2011) · low 4 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JOJ

90in 2025

2007high 224 (2012) · low 38 (2019)2026

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

Recalls per year · JOJ

1in 2023

2007high 2 (2008) · low 0 (2007)2026

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

Adverse event reports per year · JOJ

12in 2025

2007high 39 (2023) · low 1 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	8	140	0	1
2008	9	57	2	1
2009	7	188	2	9
2010	6	115	0	3
2011	13	151	2	1
2012	7	224	0	8
2013	6	212	0	6
2014	6	198	0	11
2015	8	188	0	7
2016	4	150	0	11
2017	7	172	0	35
2018	5	150	0	12
2019	12	38	0	8
2020	7	108	0	6
2021	4	87	1	29
2022	8	90	0	23
2023	4	53	1	39
2024	12	71	0	25
2025	6	90	0	12
2026	3	30	0	—

What is it indicated for?

The 3M™ Comply™ 1248 Gas Plasma Chemical Indicator is indicated for use as an internal pack process indicator to verify exposure to vapor hydrogen peroxide in the STERRAD® 100, STERRAD® 100S, and STERRAD® 50 Sterilization processes. The chemical indicator bar turns from blue to pink after exposure to vapor hydrogen peroxide in these sterilization processes.

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

https://510kreport.com/device/K013228 · printed Nov 6, 2026

Cite this page

510(k) Report. “K013228: 3M Comply 1248 Gas Plasma Chemical Indicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013228

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026