510(k) · Cleared
ClearedHU-Friedy Ims Cassette System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hu-Friedy Mfg. Co., Inc. · FSM Tray, Surgical, Instrument
Cleared on Nov 8, 1984 after a 27-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 154 devices in its family, counting itself, has a Class I recall. 153 later devices descend from it.
- Decided
- Nov 8, 1984
- Review
- 27 days
- Class
- Class I
- Product code
- FSM
- Recalls
- None
- Predicates
- 0
153 later devices descend from it, 2 citing it directly. 1 of the 154 devices in this family, counting this one, has a Class I recall.
- This deviceK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- Descendant · cites it directly · 152 of its ownK980065 C/T Med-Systems Cassette SystemC/T Med System, Ltd. · 1998
- Descendant · 2 generations on · 150 of its ownK990761 Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteTuttnauer U.S.A Co, Ltd. · 1999
- Descendant · 2 generations on · 149 of its ownK012105 Polyvac Surgical Instrument Delivery SystemSymmetry Medical, Inc. · 2002
- Descendant · 3 generations on · 58 of its ownK033222 Olympus Sterilization TraysOlympus Winter & Ibe GmbH · 2004
- Descendant · 3 generations on · 46 of its ownK040223 Polyvac Instrument Delivery SystemSymmetry Medical USA, Inc. · 2004
Showing 5 of 153 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K050220 Evis Exera Bronchovideoscope, Olympus…4 generations on · 2005
Most influential descendants
Showing 5 of 153 · See all- K980065C/T Med-Systems Cassette SystemC/T Med System, Ltd. · 1998 · cites it directly152descendants
- K990761Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteTuttnauer U.S.A Co, Ltd. · 1999 · 2 generations on150descendants
- K012105Polyvac Surgical Instrument Delivery SystemSymmetry Medical, Inc. · 2002 · 2 generations on149descendants
- K033222Olympus Sterilization TraysOlympus Winter & Ibe GmbH · 2004 · 3 generations on58descendants
- K040223Polyvac Instrument Delivery SystemSymmetry Medical USA, Inc. · 2004 · 3 generations on46descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K844002 | HU-Friedy Ims Cassette System | Hu-Friedy Mfg. Co., Inc. | 1984 | — |
| +1 | K980065 | C/T Med-Systems Cassette System | C/T Med System, Ltd. | 1998 | — |
| +2 | K990761 | Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette | Tuttnauer U.S.A Co, Ltd. | 1999 | — |
| +2 | K012105 | Polyvac Surgical Instrument Delivery System | Symmetry Medical, Inc. | 2002 | — |
| +3 | K033222 | Olympus Sterilization Trays | Olympus Winter & Ibe GmbH | 2004 | — |
| +3 | K040223 | Polyvac Instrument Delivery System | Symmetry Medical USA, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 1 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
| 2010 | 7 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 7 | 0 |
| 2014 | 4 | 0 |
| 2015 | 4 | 0 |
| 2016 | 6 | 0 |
| 2017 | 6 | 0 |
| 2018 | 11 | 0 |
| 2019 | 15 | 0 |
| 2020 | 10 | 0 |
| 2021 | 19 | 0 |
| 2022 | 9 | 0 |
| 2023 | 10 | 0 |
| 2024 | 7 | 0 |
| 2025 | 9 | 0 |
| 2026 | 5 | 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.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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? (153)
See all 1532 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K050220Evis Exera Bronchovideoscope, Olympus XBF-160Y3AC, XBF-1T160Y3AC,XBF-Q160Y2ACOlympus Medical Systems Corporation · 2005 · 4 generations on · ◆ in the 2005 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K980065 (C/T Med System, Ltd., 1998) has gone furthest, with 152 descendants of its own.
How does its category compare?
All FSM devicesFSM Tray, Surgical, Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FSM
FDA has decided no FSM device since 2007.
Median 510(k) review, days · FSM
Too few FSM 510(k)s in any year since 2007 to give a median.
Recalls per year · FSM
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FSM
274in 2025
MAUDE reports naming product code FSM, 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 | 2 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 1 | 8 |
| 2012 | 0 | — | 9 | 10 |
| 2013 | 0 | — | 0 | 81 |
| 2014 | 0 | — | 0 | 46 |
| 2015 | 0 | — | 2 | 79 |
| 2016 | 0 | — | 2 | 90 |
| 2017 | 0 | — | 0 | 132 |
| 2018 | 0 | — | 2 | 104 |
| 2019 | 0 | — | 0 | 168 |
| 2020 | 0 | — | 0 | 148 |
| 2021 | 0 | — | 1 | 153 |
| 2022 | 0 | — | 2 | 200 |
| 2023 | 0 | — | 0 | 168 |
| 2024 | 0 | — | 0 | 288 |
| 2025 | 0 | — | 0 | 274 |
| 2026 | 0 | — | 4 | — |
https://510kreport.com/device/K844002 · printed Nov 4, 2026
Cite this page
510(k) Report. “K844002: HU-Friedy Ims Cassette System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K844002
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026