510(k) · Cleared
ClearedIrradiator for Biological Materials, Ibl-137C
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cis-Us, Inc. · MOT Irradiator, Blood To Prevent Graft Versus Host Disease
Cleared on Feb 26, 1987 after a 65-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Feb 26, 1987
- Review
- 65 days
- Class
- Class U
- Product code
- MOT
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK865027 Irradiator for Biological Materials, Ibl-137CCis-Us, Inc. · 1987
- Descendant · cites it directly · 4 of its ownK974210 Shielded Cabinet X-Ray Radiation Source Device Model RS 3000Rad-Source, Inc. · 1998 · Recalled
- Descendant · 2 generations on · 2 of its ownK082921 Rad Source X-Ray Blood Irradiator, Model RS-3400Rad Source Technologies, Inc. · 2009
- Descendant · 3 generations on · 1 of its ownK172087 SangrayHitachi, Ltd. · 2017
- Descendant · 4 generations on · 0 of its ownK201177 RadGil2R3 X-Ray L.L.C · 2020
- Descendant · 2 generations on · 0 of its ownK032684 RaycellMds Nordion · 2003
Most influential descendants
Showing 5 of 5 · See all- K974210Shielded Cabinet X-Ray Radiation Source Device Model RS 3000Rad-Source, Inc. · 1998 · cites it directly4descendants
- K082921Rad Source X-Ray Blood Irradiator, Model RS-3400Rad Source Technologies, Inc. · 2009 · 2 generations on2descendants
- K172087SangrayHitachi, Ltd. · 2017 · 3 generations on1descendant
- K201177RadGil2R3 X-Ray L.L.C · 2020 · 4 generations on0descendants
- K032684RaycellMds Nordion · 2003 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K865027 | Irradiator for Biological Materials, Ibl-137C | Cis-Us, Inc. | 1987 | — |
| +1 | K974210 | Shielded Cabinet X-Ray Radiation Source Device Model RS 3000 | Rad-Source, Inc. | 1998 | 1 |
| +2 | K082921 | Rad Source X-Ray Blood Irradiator, Model RS-3400 | Rad Source Technologies, Inc. | 2009 | — |
| +3 | K172087 | Sangray | Hitachi, Ltd. | 2017 | — |
| +4 | K201177 | RadGil2 | R3 X-Ray L.L.C | 2020 | — |
| +2 | K032684 | Raycell | Mds Nordion | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
| 2009 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MOT? 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 MOT device
- #1 K201177 RadGil2score 0.8 · 4 generations · no Class I recall
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K974210 | Shielded Cabinet X-Ray Radiation Source Device Model RS 3000 | 1998 | 4 |
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?
- Of its descendants, K974210 (Rad-Source, Inc., 1998) has gone furthest, with 4 descendants of its own.
How does its category compare?
All MOT devicesMOT Irradiator, Blood To Prevent Graft Versus Host Disease: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MOT
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · MOT
Too few MOT 510(k)s in any year since 2007 to give a median.
Recalls per year · MOT
No recall names MOT since 2007.
Adverse event reports per year · MOT
1in 2014
MAUDE reports naming product code MOT, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K865027 · printed Nov 6, 2026
Cite this page
510(k) Report. “K865027: Irradiator for Biological Materials, Ibl-137C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K865027
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026