510(k) Report

510(k) · Cleared

Recalled · Class II · 2020

Seednet, Models FP6T5, FP5T5, FP5T3

K010991510(k) SpecialCleared May 3, 200130-day reviewClass II21 CFR 878.4350Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Galil Medical, Ltd. · GEH Unit, Cryosurgical, Accessories

Cleared on May 3, 2001 after a 30-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 34 later devices descend from it. It has been recalled 2 times.

Decided
May 3, 2001
Review
30 days
Class
Class II
Product code
GEH
Recalls
2
Predicates
0

34 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2002: 2 descendants cleared2006: 1 descendant cleared2009: 1 descendant cleared2012: 2 descendants cleared2014: 2 descendants cleared2003: 1 descendant cleared2013: 1 descendant cleared2023: 4 descendants cleared2015: 2 descendants cleared2018: 2 descendants cleared2020: 4 descendants cleared2004: 1 descendant cleared2016: 3 descendants cleared2024: 2 descendants cleared2025: 2 descendants cleared2017: 1 descendant cleared2021: 1 descendant cleared2022: 1 descendant cleared2026: 1 descendant cleared200020052010201520202025
  1. This deviceK010991 Seednet, Models FP6T5, FP5T5, FP5T3Galil Medical, Ltd. · 2001
  2. Descendant · cites it directly · 33 of its ownK011950 Seednet, Model FP6T5, FP5T5, FP5T3Galil Medical, Ltd. · 2002
  3. Descendant · 2 generations on · 32 of its ownK021261 Seednet System and Seednetgold System, Models GP6T5, GP5T5, GP5T3…Galil Medical, Ltd. · 2002 · Recalled
  4. Descendant · 3 generations on · 31 of its ownK031117 Seednet System and Seednetgold SystemGalil Medical, Ltd. · 2003
  5. Descendant · 4 generations on · 29 of its ownK042667 Seednet Gold with Renal Kit, Model Fprpr 3021, (Renal Kit), Fprch…Galil Medical, Ltd. · 2004
  6. Descendant · cites it directly · 28 of its ownK060390 Seednet, Seednet Gold, Cryohit, Cryo TheraGalil Medical, Ltd. · 2006 · Recalled

Showing 5 of 34 descendants. See all descendants

Descendants cleared per year

2002: 22003: 12004: 12006: 12009: 12012: 22013: 12014: 22015: 22016: 32017: 12018: 22020: 42021: 12022: 12023: 42024: 22025: 22026: 1
2002high 4 (2020) · low 0 (2005)2026

Most influential descendants

Showing 5 of 34 · See all
  • K011950Seednet, Model FP6T5, FP5T5, FP5T3Galil Medical, Ltd. · 2002 · cites it directly33descendants
  • K021261Seednet System and Seednetgold System, Models GP6T5, GP5T5, GP5T3, HP5T5 & HP5T3Galil Medical, Ltd. · 2002 · 2 generations on32descendants
  • K031117Seednet System and Seednetgold SystemGalil Medical, Ltd. · 2003 · 3 generations on31descendants
  • K042667Seednet Gold with Renal Kit, Model Fprpr 3021, (Renal Kit), Fprch 2024 (Seednetgold)Galil Medical, Ltd. · 2004 · 4 generations on29descendants
  • K060390Seednet, Seednet Gold, Cryohit, Cryo TheraGalil Medical, Ltd. · 2006 · cites it directly28descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K010991Seednet, Models FP6T5, FP5T5, FP5T3Galil Medical, Ltd.2001—
+1K011950Seednet, Model FP6T5, FP5T5, FP5T3Galil Medical, Ltd.2002—
+2K021261Seednet System and Seednetgold System, Models GP6T5, GP5T5, GP5T3, HP5T5 & HP5T3Galil Medical, Ltd.20021
+3K031117Seednet System and Seednetgold SystemGalil Medical, Ltd.2003—
+4K042667Seednet Gold with Renal Kit, Model Fprpr 3021, (Renal Kit), Fprch 2024…Galil Medical, Ltd.2004—
+1K060390Seednet, Seednet Gold, Cryohit, Cryo TheraGalil Medical, Ltd.20068

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200220
200310
200410
200610
200910
201220
201310
201420
201520
201630
201710
201820
202040
202110
202210
202340
202420
202520
202610
FIG. 1 — Lineage of K010991, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 GEH? 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 GEH device

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  2. #2 Held for the reportin the report
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Get a 510(k) 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? (34)

See all 34

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K011950Seednet, Model FP6T5, FP5T5, FP5T3Galil Medical, Ltd.200233
K060390Seednet, Seednet Gold, Cryohit, Cryo TheraGalil Medical, Ltd.200628

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Nov 18, 2020Class IIZ-0687-2021Under Investigation by firmComplaint trend regarding needle shaft gas leaks.
Nov 11, 2010Not classifiedZ-0832-2011OtherThis voluntary recall has been initiated because our supplier (Gaymar Industries, Inc.) notified us that these products contain power cords that may crack or fail at or inside the plug due to a prong design problem. Affected plugs can be…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K011950 (Galil Medical, Ltd., 2002) has gone furthest, with 33 descendants of its own.

How does its category compare?

All GEH devices

GEH Unit, Cryosurgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEH

10in 2025

2007: 62008: 12009: 42010: 42011: 72012: 42013: 42014: 62015: 112016: 152017: 122018: 62019: 62020: 82021: 62022: 62023: 82024: 92025: 102026 (partial year): 8
2007high 15 (2016) · low 1 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEH

77in 2025

2007: 71 days median2009: 121 days median2010: 86 days median2011: 91 days median2012: 96 days median2013: 76 days median2014: 42 days median2015: 72 days median2016: 60 days median2017: 83 days median2018: 42 days median2019: 115 days median2020: 113 days median2021: 206 days median2022: 56 days median2023: 136 days median2024: 85 days median2025: 77 days median2026 (partial year): 148 days median
2007high 206 (2021) · low 42 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEH

2in 2023

2007: 32008: 22009: 132010: 42012: 32014: 22018: 12019: 12020: 372023: 22026 (partial year): 2
2007high 37 (2020) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GEH

171in 2025

2007: 232008: 292009: 212010: 1732011: 612012: 912013: 912014: 572015: 972016: 1432017: 2162018: 2082019: 4552020: 2772021: 2132022: 2302023: 1642024: 1412025: 171
2007high 455 (2019) · low 21 (2009)2025

MAUDE reports naming product code GEH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007671323
20081—229
200941211321
20104864173
2011791061
2012496391
2013476091
2014642257
20151172097
201615600143
201712830216
20186421208
201961151455
2020811337277
202162060213
20226560230
202381362164
20249850141
202510770171
202681482—

More from Galil Medical, Ltd.

23 FDA decisions under this applicant name. See the company

  • K181741IceSphere 1.5 CX Cryoablation NeedleGalil Medical, Ltd. · 20181 recall
  • K162599IcePearl 2.1 CX L, IceForce 2.1 CX LGalil Medical, Ltd. · 20162 recalls
  • K152133IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit Visual-ICE System, IceFORCE…Galil Medical, Ltd. · 201518 recalls
  • K141485Icesphere 1.5 90 Cryoblation Needle, Iceshpere 1.5 Cyoblation NeedleGalil Medical, Ltd. · 20143 recalls
  • K140584Icerod CX Cryoablation NeedleGalil Medical, Ltd. · 2014

Recent decisions in GEH

The GEH category page

  • K262420Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)Serpex Medical · 2026
  • K261068Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)Serpex Medical · 2026
  • K261806ERBECRYO 2 Cryosurgical Unit and AccessoriesErbe Elektromedizin GmbH · 2026
  • K253230ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible CryoprobeErbe Elektromedizin GmbH · 2026
  • K252198Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)Medical Brands Laboratories B.V. · 2026

https://510kreport.com/device/K010991 · printed Nov 4, 2026

Cite this page

510(k) Report. “K010991: Seednet, Models FP6T5, FP5T5, FP5T3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K010991

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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