510(k) · Cleared

Cleared

Namsa Chemical Process

K132291510(k) TraditionalCleared May 20, 2014301-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

North American Science Assoc., Inc. · JOJ Indicator, Physical/Chemical Sterilization Process

Cleared on May 20, 2014 as substantially equivalent to K951113 (Steritec Products Mfg Co, Inc., 1996) after a 301-day review. Its family tree reaches back 1 generation to 1996.

Decided: May 20, 2014
Review: 301 days
Class: Class II
Product code: JOJ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K951113 (1996). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK951113 Cross-ChecksSteritec Products Mfg Co, Inc. · 1996
This deviceK132291 Namsa Chemical ProcessNorth American Science Assoc., Inc. · 2014

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K951113	Cross-Checks	Steritec Products Mfg Co, Inc.	1996	—
0 (this device)	K132291	Namsa Chemical Process	North American Science Assoc., Inc.	2014	—

FIG. 1 — Lineage of K132291, 1996–2014Source: 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

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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.

Type	Number	Device	Applicant	Decided	Recalls
*	K951113	Cross-Checks Summary page 1 …cator/Chemical Process Indicator Trade Name: NAMSA REIF TST4-S Predicate Devices: SteriTec Cross-Checks Indicator, REIF Cl 107 K951113 SteriTec Products Mfg. Co., Inc. Statement of Intended Use: The NAMSA Chemical…	Steritec Products Mfg Co, Inc.	1996	—

Also cleared against K951113: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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?

Its one ancestor has no recall.
1 other device also cites its predicate K951113.

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. 2014, this device’s year, is highlighted.

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 NAMSA Chemical Process Indicator Strip for Steam, REF TST4-S Is intended for use with individual materials (i.e. pouches, pack, tray) to demonstrate that the material has been exposed to a steam sterilization process to distinguish between processed and unprocessed goods.

The NAMSA Chemical Process Indicator Strip for Steam will transition from an initial yellow color to a dark brown/black signal color when exposed to high temperature steam at the following time and temperature intervals as a process indicator:

* 1210C for 30 minutes (gravity cycle)

*1 34*C for 3 minutes (pre-vacuum cycle)

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K132291 · printed Nov 4, 2026

Cite this page

510(k) Report. “K132291: Namsa Chemical Process.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K132291

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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