Attest™
3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack for 132°C 4-min and 135 degree C 3-min Steam Sterilization, 24/Case 41482VF
1manufacturer
36catalogue numbers in this listing
32510(k) clearances naming this product code
9recalls on this code
Who Else Makes It
Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
Record
| Listed by | 3M Company, United States |
|---|---|
| FDA product code | FRC |
| Device type | Indicator, Biological Sterilization Process |
| Device class | Class 2 |
| Regulation | 21 CFR 880.2800 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K121593 |
| Record published | 2016-09-24 |
| Record revised | 2023-04-27 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Box of 4, box of 2 |
| Distribution end date | 2023-04-27 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 41482V | 24 | In distribution | |
| 1264P | 25 | In distribution | |
| 1295 | 30 | In distribution | |
| 1261 | 100 | In distribution | |
| 1262 | 100 | In distribution | |
| 490 | In distribution | ||
| 1261P | 25 | In distribution | |
| 1278 | 25 | In distribution | |
| 490H | In distribution | ||
| 1291 | 50 | In distribution | |
| 1292 | 50 | In distribution | |
| 1496V | 24 | In distribution | |
| 1264 | 100 | In distribution | |
| 1276 | 25 | In distribution | |
| 1492V | 50 | In distribution | |
| 390G | In distribution | ||
| 1262P | 25 | In distribution | |
| 1262P | 25 | In distribution | |
| 1276F | 25 | In distribution | |
| 41380 | 16 | In distribution | |
| 115 | In distribution | ||
| 1296F | 25 | In distribution | |
| 1491 | 50 | In distribution | |
| 1278F | 25 | In distribution | |
| 41482VF | 24 | In distribution | |
| 1294 | 50 | In distribution | |
| 490H | In distribution | ||
| 41382F | 16 | In distribution | |
| 1298 | 25 | In distribution | |
| 41382 | 16 | In distribution | |
| 116K | In distribution | ||
| 390 | In distribution | ||
| 1296 | 25 | In distribution | |
| 1496VF | 24 | In distribution | |
| 1298F | 25 | In distribution | |
| 1261P | 25 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bionova® | Terragene S.A. | 47 |
| Verify | Steris Corporation | 27 |
| 3M™ Attest™ | 3M Company | 16 |
| Celerity | Steris Corporation | 15 |
| Biotrace™ | Terragene S.A. | 11 |
| Single Species BI Strip | Crosstex International | 11 |
| Tuttnauer® | Terragene S.A. | 10 |
| Sterrad Velocity™ | Advanced Sterilization Products Services Inc. | 8 |
| GPS | Group Practice Solutions | 7 |
| Henry Schein | Henry Schein, Inc. | 7 |
| Propper Duo Spore Biological Indicators | Propper Manufacturing Co., Inc. | 7 |
| Spore Strip Steam & Chemiclave | Mesa Laboratories, Inc. | 6 |
Showing 12 of 173. All products under Indicator, Biological Sterilization Process
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K243501 | 2025-01-28 |
| K242538 | 2024-11-25 |
| K241959 | 2024-10-18 |
| K241710 | 2024-09-12 |
| K240717 | 2024-06-27 |
| K241542 | 2024-06-27 |
| K233814 | 2024-03-15 |
| K211705 | 2022-06-28 |
| K213809 | 2022-04-06 |
| K210277 | 2021-03-03 |
| K200996 | 2020-12-11 |
| K200766 | 2020-07-02 |
| K192550 | 2020-06-05 |
| K200092 | 2020-04-15 |
| K193154 | 2020-02-07 |
| K173519 | 2018-04-23 |
| K173437 | 2018-03-19 |
| K173435 | 2018-02-09 |
| K173584 | 2018-01-22 |
| K171003 | 2017-07-21 |
| K160546 | 2016-06-09 |
| K152060 | 2015-12-01 |
| K140392 | 2014-08-13 |
| K123546 | 2013-03-18 |
| K121593 | 2013-03-15 |
| K121484 | 2012-10-19 |
| K101910 | 2010-12-08 |
| K090569 | 2009-04-29 |
| K052128 | 2005-08-16 |
| K031012 | 2003-10-16 |
| K004009 | 2002-03-25 |
| K900771 | 1990-07-03 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| 3M Company | UDI-DI | 2023-08-22 | Class II | Process control | Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rapid 5 Steam-Plus Challenge (41482V, 41482VF), and 3M Attest Super Rapid Readout Steam Challenge (1496V) may contain biological indicators with a | 79500 devices | |
| 3M Company | UDI-DI | 2023-08-22 | Class II | Process control | Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rapid 5 Steam-Plus Challenge (41482V, 41482VF), and 3M Attest Super Rapid Readout Steam Challenge (1496V) may contain biological indicators with a | 33504 devices | |
| 3M Company | 510(k) number | 2014-06-09 | Class II | Labeling Change Control | Labeling on units shipped prior to May 16th, 2014 did not contain the statement “This product contains dry natural rubber” as required by the United States Food and Drug Administration (FDA) for medical devices. The non-slip pads at the bo | 5343 (2621 USA, 2722 OUS) | 2015-06-03 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2023-08-22 | Class II | Process control | Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rapid 5 Steam-Plus Challenge (41482V, 41482VF), and 3M Attest Super Rapid Readout Steam Challenge (1496V) may contain biological indicators with a | 77,280 devices | |
| 2023-08-22 | Class II | Process control | Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rapid 5 Steam-Plus Challenge (41482V, 41482VF), and 3M Attest Super Rapid Readout Steam Challenge (1496V) may contain biological indicators with a | 172,464 devices | |
| 2004-02-27 | Not classified | Other | The 3M Attest 1292 Rapid Readout Biological Indicators for steam sterilization may contain ampoules which may result in a false negative readout at 3 hours. | 90,000 ampoules | 2006-12-28 |
| 2003-10-24 | Not classified | Other | The 3M Attest 1264/1264P Biological Indicators of ETO sterilization contain a microbiological contaminant which can affect the performance of the positive control and the indicators to some limited extent. The color on a positive control ma | 1844 boxes of 25 biological indicators per box | 2005-02-09 |
| 2003-10-24 | Not classified | Other | The 3M Attest 1264/1264P Biological Indicators of ETO sterilization contain a microbiological contaminant which can affect the performance of the positive control and the indicators to some limited extent. The color on a positive control m | 9592 boxes of 100 biological indicators per box | 2005-02-09 |
| 2002-01-09 | Not classified | Other | Some 3M Attest Steam Packs 1276F (biological indicator challenge for steam sterilization) were labeled as 3M Attest Rapid Readout Steam Pack 1296F. | 2003-05-09 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.