510(k) · Cleared
Cleared3M Comply Lead Free Steam Indicator Tape 1322, 3M Attest Lead Free Steam Indicator Tape 1355
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Company · JOJ Indicator, Physical/Chemical Sterilization Process
Cleared on May 23, 2022 as substantially equivalent to K101528 (3M Company, 2010) after an 84-day review. Its family tree reaches back 2 generations to 1994. 1 later device descends from it.
- Decided
- May 23, 2022
- Review
- 84 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K932129 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK932129 3M Autoclave Tapes3M Company · 1994
- 1 generation backK101528 3M Comply Lead Free Process Indicators for Steam3M Company · 2010 · Recalled
- This deviceK220564 3M Comply Lead Free Steam Indicator Tape 1322, 3M Attest Lead Free…3M Company · 2022
- Descendant · cites it directly · 0 of its ownK251991 SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014…Shenzhen Safesecure Medical Infection Control Tech Co., Ltd. · 2025
Most influential descendants
Showing 1 of 1 · See all- K251991SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure…Shenzhen Safesecure Medical Infection Control Tech Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K932129 | 3M Autoclave Tapes | 3M Company | 1994 | — |
| −1 | K101528 | 3M Comply Lead Free Process Indicators for Steam | 3M Company | 2010 | 1 |
| 0 (this device) | K220564 | 3M Comply Lead Free Steam Indicator Tape 1322, 3M Attest Lead Free Steam… | 3M Company | 2022 | — |
| +1 | K251991 | SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016)… | Shenzhen Safesecure Medical Infection Control Tech Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K101528 | 3M Comply Lead Free Process Indicators for SteamSummary page 5…220564 Device Classification: Class II, 21 CFR § 880.2800(b) Product Code: JOJ 2. Date of Preparation: May 18, 2022 3. Predicate Device: K101528, Comply 1322 Lead Free Indicator Tape 4. Device Description: 3M™ Comply™ Lead Free Steam Indicator Tape 1322 The 3M™ Comp… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251991 | SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure… | 2025 | 0 |
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 28 years and passes through 1 company; a new generation was cleared every 16.6 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K251991 (Shenzhen Safesecure Medical Infection Control Tech Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K101528.
How does its category compare?
All JOJ devicesJOJ Indicator, Physical/Chemical Sterilization Process: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · JOJ
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JOJ
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JOJ
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JOJ
12in 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?
3M™ Comply™ Lead Free Steam Indicator Tape 1322 is designed for use by a health care provider to accompany individual units (e.g. wrapped packs) to demonstrate that the unit has been exposed to the sterilization process and to distinguish between processed and unprocessed units. Use the 3M™ Comply™ Lead Free Steam Indicator Tape 1322 in steam process below: Cycle Type Temperature Exposure Time Gravity 250 °F/121°C 30 minutes Gravity 270 °F/132°C 3, 4…
Read the full statement (334 words)
3M™ Comply™ Lead Free Steam Indicator Tape 1322 is designed for use by a health care provider to accompany individual units (e.g. wrapped packs) to demonstrate that the unit has been exposed to the sterilization process and to distinguish between processed and unprocessed units. Use the 3M™ Comply™ Lead Free Steam Indicator Tape 1322 in steam process below:
Cycle Type Temperature Exposure Time
Gravity 250 °F/121°C 30 minutes
Gravity 270 °F/132°C 3, 4, 10, 15, 25 minutes
Gravity 275 °F/135°C 3, 10 minutes
Dynamic air-removal 250 °F/121°C 15, 20, 30 minutes
Dynamic air-removal 270 °F/132°C 3, 3.5, 4, 5.5, 6, 9, 10, 15 minutes
Dynamic air-removal 273 °F/134°C 3, 3.5, 4 minutes
Dynamic air-removal 275 °F/135°C 3, 3.5, 4, 10 minutes
Use the 3M™ Comply™ Lead Free Steam Indicator Tape 1322 to demonstrate that packs have been exposed to the sterilization process. The 3M™ Comply™ Lead Free Steam Indicator Tape 1322 is designed to secure packs wrapped with untreated woven and disposable non-woven paper and paper/plastic wraps.
3M™ Attest™ Lead Free Steam Indicator Tape 1355 for disposable wraps is designed for use by a health care provider to accompany individual units (e.g., wrapped packs) to demonstrate that the unit has been exposed to the sterilization process and to distinguish between processed and unprocessed units. Use the 3M™ Attest™ Lead Free Steam Indicator Tape 1355 in steam process below:
Cycle Type Temperature Exposure Time
Gravity 250 °F/121°C 30 minutes
Gravity 270 °F/132°C 3, 4, 10, 15, 25 minutes
Gravity 275 °F/135°C 3, 10 minutes
Dynamic air-removal 250 °F/121°C 15, 20, 30 minutes
Dynamic air-removal 270 °F/132°C 3, 3.5, 4, 5.5, 6, 9, 10, 15 minutes
Dynamic air-removal 273 °F/134°C 3, 3.5, 4 minutes
Dynamic air-removal 275 °F/135°C 3, 3.5, 4, 10 minutes
Use the 3M™ Attest™ Lead Free Steam Indicator Tape 1355 to demonstrate that packs have been exposed to the sterilization process. The 3M™ Attest™ Lead Free Steam Indicator Tape 1355 is designed to secure packs wrapped with disposable non-woven, paper and paper/plastic wraps.
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/K220564 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220564: 3M Comply Lead Free Steam Indicator Tape 1322, 3M Attest Lead Free Steam Indicator Tape 1355.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220564
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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