510(k) · Cleared
Recalled · Class II · 2014Sterrad 200 Sterilizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Sterilization Products · MLR Sterilizer, Chemical
Cleared on Aug 18, 2003 after a 189-day review. The FDA summary names its predicate without a number. 11 later devices descend from it. It has been recalled 8 times.
- Decided
- Aug 18, 2003
- Review
- 189 days
- Class
- Class II
- Product code
- MLR
- Recalls
- 8
- Predicates
- 0
11 later devices descend from it, 1 citing it directly.
- This deviceK030429 Sterrad 200 SterilizerAdvanced Sterilization Products · 2003
- Descendant · cites it directly · 10 of its ownK092622 Sterrad 100NX Sterilizer Express CycleAdvanced Sterilization Products · 2011
- Descendant · 2 generations on · 9 of its ownK142454 STERRAD NX Sterilizer, STERRAD 100NX SterilizerAdvanced Sterilization Products · 2015 · Recalled
- Descendant · 2 generations on · 4 of its ownK160903 STERRAD 100NX Sterilizer with ALLClearTM TechnologyAdvanced Sterilization Products · 2016
- Descendant · 3 generations on · 3 of its ownK212174 STERRAD 100NX Sterilizer with ALLClear TechnologyAdvanced Sterilization Products, Inc. · 2021
- Descendant · 4 generations on · 2 of its ownK234082 STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™…Advanced Sterilization Products · 2024
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K092622Sterrad 100NX Sterilizer Express CycleAdvanced Sterilization Products · 2011 · cites it directly10descendants
- K142454STERRAD NX Sterilizer, STERRAD 100NX SterilizerAdvanced Sterilization Products · 2015 · 2 generations on9descendants
- K160903STERRAD 100NX Sterilizer with ALLClearTM TechnologyAdvanced Sterilization Products · 2016 · 2 generations on4descendants
- K212174STERRAD 100NX Sterilizer with ALLClear TechnologyAdvanced Sterilization Products, Inc. · 2021 · 3 generations on3descendants
- K234082STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104)…Advanced Sterilization Products · 2024 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K030429 | Sterrad 200 Sterilizer | Advanced Sterilization Products | 2003 | — |
| +1 | K092622 | Sterrad 100NX Sterilizer Express Cycle | Advanced Sterilization Products | 2011 | — |
| +2 | K142454 | STERRAD NX Sterilizer, STERRAD 100NX Sterilizer | Advanced Sterilization Products | 2015 | 2 |
| +2 | K160903 | STERRAD 100NX Sterilizer with ALLClearTM Technology | Advanced Sterilization Products | 2016 | — |
| +3 | K212174 | STERRAD 100NX Sterilizer with ALLClear Technology | Advanced Sterilization Products, Inc. | 2021 | — |
| +4 | K234082 | STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle… | Advanced Sterilization Products | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 MLR? 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 MLR device
- #1 K250802 STERRAD® 100NX Sterilizer with ALLClear™…score 14.0 · 7 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 |
|---|---|---|---|
| * | — | STERRAD 100s Sterilization System Named without a submission number |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092622 | Sterrad 100NX Sterilizer Express Cycle | 2011 | 10 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 4, 2014 | Class II | Z-0844-2015 | Nonconforming Material/Component | Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not function properly after exposure to hydrogen peroxide. |
| Sep 18, 2013 | Class II | Z-0043-2014 | Under Investigation by firm | Advanced Sterilization Products (ASP) is recalling the STERRAD 200 Sterilization System because it may emit an odor or smell into the surrounding environment that is not typical to normal operating conditions. |
| Mar 22, 2013 | Class II | Z-1027-2013 | Nonconforming Material/Component | The recall was initiated because Advanced Sterilization Products (ASP) has determined that the STERRAD 100NX and STERRAD 200 Sterilization Systems may emit an odor or smell into the surrounding environment that is not typical to normal… |
| Mar 13, 2012 | Class II | Z-0998-2013 | Device Design | Advanced Sterilization Products (ASP) is recalling the STERRAD 200 System Carriage because it can potentially become dislodged when an excessive load is applied. |
| Jan 23, 2012 | Not classified | Z-0741-2012 | Nonconforming Material/Component | ASP determined that an internal filter in the vacuum pump on the STERRAD 200 System is subject to wear over time. |
| Feb 25, 2008 | Not classified | Z-1630-2008 | Device Design | Oil mist filter fails allowing oil mist to be emitted into the vicinity of the sterilizer, which may result in the release of a mist, "haze," or "smoke." |
| Nov 12, 2007 | Not classified | Z-0844-2008 | Other | Outdated Compatibility Lists: Recalling firm has decided to discontinue dissemination of Compatible Medical Device Reference Lists and instrument assessment activities |
| Nov 12, 2007 | Not classified | Z-0845-2008 | Employee error | User Guide Update: based on user reports about contact with residual hydrogen peroxide from instruments, pouches and trays after sterilization and subsequent light colored residue on these devices after sterilization updated user guidance… |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K092622 (Advanced Sterilization Products, 2011) has gone furthest, with 10 descendants of its own.
How does its category compare?
All MLR devicesMLR Sterilizer, Chemical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MLR
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MLR
216in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MLR
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MLR
46in 2025
MAUDE reports naming product code MLR, 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 | 2 | — | 5 | 272 |
| 2008 | 0 | — | 8 | 536 |
| 2009 | 1 | — | 2 | 433 |
| 2010 | 0 | — | 1 | 211 |
| 2011 | 6 | 214 | 2 | 34 |
| 2012 | 2 | — | 3 | 101 |
| 2013 | 1 | — | 9 | 541 |
| 2014 | 2 | — | 3 | 399 |
| 2015 | 1 | — | 0 | 412 |
| 2016 | 4 | 183 | 0 | 286 |
| 2017 | 2 | — | 1 | 279 |
| 2018 | 2 | — | 0 | 289 |
| 2019 | 4 | 90 | 0 | 222 |
| 2020 | 0 | — | 0 | 174 |
| 2021 | 2 | — | 0 | 202 |
| 2022 | 2 | — | 0 | 188 |
| 2023 | 5 | 222 | 0 | 140 |
| 2024 | 3 | 216 | 0 | 44 |
| 2025 | 1 | — | 0 | 46 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The STERRAD® 200 Sterilizer is designed for sterilization of both metal and nonmetal medical devices at low temperatures. Because the cycle operates within a dry environment and at low temperatures, it is especially suitable for instruments sensitive to heat and moisture. The STERRAD® 200 Sterilizer can sterilize instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors. Medical devices with only a single…
Read the full statement (247 words)
The STERRAD® 200 Sterilizer is designed for sterilization of both metal and nonmetal medical devices at low temperatures. Because the cycle operates within a dry environment and at low temperatures, it is especially suitable for instruments sensitive to heat and moisture.
The STERRAD® 200 Sterilizer can sterilize instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.
Medical devices with only a single stainless steel lumen with the following dimensions can be processed in the STERRAD® 200 Sterilizer.
An inside diameter of 1 mm or larger and a length of 125 mm or shorter*
An inside diameter of 2 mm or larger and a length of 250 mm or shorter*
An inside diameter of 3 mm or larger and a length of 400 mm or shorter
Teflon® and polyethylene lumen instruments with inside diameters of 6 mm or larger and lengths of 310 mm or shorter can be processed in the STERRAD® 200 Sterilizer.
*The validation testing for this lumen size was conducted using a maximum of 12 lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing.
Note: The validation studies for this sterilizer were performed using the STERRAD cycle consisting of a 6-minute 45-second injection phase followed by a 2-minute diffusion phase and a 2-minute plasma phase. The validation studies were performed using a validation load consisting of four instrument trays each weighing 9.12 lbs. (the total weight of the load was 36.48 lbs.).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030429 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030429: Sterrad 200 Sterilizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030429
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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