510(k) · Cleared
ClearedMDT Unispore and Spor-Test Biologicalindicator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mdt Corp., Inc. · FRC Indicator, Biological Sterilization Process
Cleared on May 23, 1996 as substantially equivalent to K792649 (Castle Co., 1980) and 2 other predicates after an 87-day review. Its family tree reaches back 1 generation to 1980. 4 later devices descend from it.
- Decided
- May 23, 1996
- Review
- 87 days
- Class
- Class II
- Product code
- FRC
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K792649 (1980). 3 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK792649 Unispore-Biological IndicatorsCastle Co. · 1980
- This deviceK960777 MDT Unispore and Spor-Test BiologicalindicatorMdt Corp., Inc. · 1996
- Descendant · cites it directly · 3 of its ownK020205 Castle Peracetic Acid Biological Indicator KitGetinge/Castle, Inc. · 2002
- Descendant · 2 generations on · 1 of its ownK043135 Spsmedical Sporview PA Culture SetSpsmedical Supply Corp. · 2005
- Descendant · 3 generations on · 0 of its ownK081879 Spsmedical Sporview PA Culture SetSpsmedical Supply Corp. · 2008
- Descendant · 2 generations on · 0 of its ownK050664 Spor-Test PA Biological Indicator KitGetinge USA, Inc. · 2005
Most influential descendants
Showing 4 of 4 · See all- K020205Castle Peracetic Acid Biological Indicator KitGetinge/Castle, Inc. · 2002 · cites it directly3descendants
- K043135Spsmedical Sporview PA Culture SetSpsmedical Supply Corp. · 2005 · 2 generations on1descendant
- K081879Spsmedical Sporview PA Culture SetSpsmedical Supply Corp. · 2008 · 3 generations on0descendants
- K050664Spor-Test PA Biological Indicator KitGetinge USA, Inc. · 2005 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K792649 | Unispore-Biological Indicators | Castle Co. | 1980 | — |
| 0 (this device) | K960777 | MDT Unispore and Spor-Test Biologicalindicator | Mdt Corp., Inc. | 1996 | — |
| +1 | K020205 | Castle Peracetic Acid Biological Indicator Kit | Getinge/Castle, Inc. | 2002 | — |
| +2 | K043135 | Spsmedical Sporview PA Culture Set | Spsmedical Supply Corp. | 2005 | — |
| +3 | K081879 | Spsmedical Sporview PA Culture Set | Spsmedical Supply Corp. | 2008 | — |
| +2 | K050664 | Spor-Test PA Biological Indicator Kit | Getinge USA, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 2 | 0 |
| 2008 | 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 FRC? 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 FRC device
- #1 K250044 Celerity 5 HP Biological Indicator (LCB052)…score 14.5 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K792649 | Unispore-Biological IndicatorsSummary page 2…a)(2) We believe this product to be substantially equivalent to the Unispore® and Spor-Test® biological indicators currently having market clearance in accordance with K792649 & K801152 and K800482, & K801980 respectively. ref. 21 CFR 807.92(a)(3) The MDT Biologic Company Unispore® and Spor-Test® Biolo… | 1980 |
| Kept off the family tree | K801152 | Unispore® biological indicators Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 2…believe this product to be substantially equivalent to the Unispore® and Spor-Test® biological indicators currently having market clearance in accordance with K792649 & K801152 and K800482, & K801980 respectively. ref. 21 CFR 807.92(a)(3) The MDT Biologic Company Unispore® and Spor-Test® Biological Indi… | |
| * | K800482 | Stearothermohilus Spore StripsSummary page 2…product to be substantially equivalent to the Unispore® and Spor-Test® biological indicators currently having market clearance in accordance with K792649 & K801152 and K800482, & K801980 respectively. ref. 21 CFR 807.92(a)(3) The MDT Biologic Company Unispore® and Spor-Test® Biological Indicators are i… | 1980 |
| * | K801980 | Spor-Test Culture MediaSummary page 2…be substantially equivalent to the Unispore® and Spor-Test® biological indicators currently having market clearance in accordance with K792649 & K801152 and K800482, & K801980 respectively. ref. 21 CFR 807.92(a)(3) The MDT Biologic Company Unispore® and Spor-Test® Biological Indicators are intended to… | 1980 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K020205 | Castle Peracetic Acid Biological Indicator Kit | 2002 | 3 |
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?
- None of the 3 ancestors has a recall.
- Of its descendants, K020205 (Getinge/Castle, Inc., 2002) has gone furthest, with 3 descendants of its own.
How does its category compare?
All FRC devicesFRC Indicator, Biological Sterilization Process: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FRC
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRC
29in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRC
8so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FRC
9in 2025
MAUDE reports naming product code FRC, 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 | 3 | 83 | 0 | 100 |
| 2008 | 1 | — | 0 | 60 |
| 2009 | 6 | 183 | 1 | 45 |
| 2010 | 4 | 165 | 0 | 57 |
| 2011 | 6 | 118 | 0 | 37 |
| 2012 | 9 | 178 | 2 | 46 |
| 2013 | 4 | 260 | 2 | 39 |
| 2014 | 13 | 174 | 0 | 51 |
| 2015 | 3 | 130 | 0 | 182 |
| 2016 | 2 | — | 0 | 482 |
| 2017 | 10 | 130 | 0 | 182 |
| 2018 | 18 | 97 | 0 | 22 |
| 2019 | 5 | 88 | 0 | 30 |
| 2020 | 10 | 150 | 0 | 16 |
| 2021 | 5 | 107 | 0 | 10 |
| 2022 | 5 | 193 | 4 | 9 |
| 2023 | 6 | 190 | 1 | 20 |
| 2024 | 8 | 105 | 0 | 22 |
| 2025 | 6 | 29 | 0 | 9 |
| 2026 | 1 | — | 8 | — |
What is it indicated for?
The MDT Biologic Company Unispore® and Spor-Test® Biological Indicators are intended to be used for the monitoring of sterilization processes in health care facilities. A biological indicator is a calibrated population of bacterial spores (of high resistance to the sterilization process monitored) on or in a carrier, put up in a package which maintains the integrity of the inoculated carrier and which is of convenience to the ultimate user, that serves to demonstrate whether sterilization conditions are met.
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/K960777 · printed Nov 4, 2026
Cite this page
510(k) Report. “K960777: MDT Unispore and Spor-Test Biologicalindicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960777
Report an extraction error
Are you the manufacturer?
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