510(k) Report

510(k) · Cleared

Cleared

Various Cardiac Cryoprobes Having Dia. & Cos. Diff

K874367510(k) TraditionalCleared Jan 4, 198873-day reviewClass II21 CFR 886.4115

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

Spembly Medical, Ltd. · HQO Unit, Cautery, Thermal, Ac-Powered

Cleared on Jan 4, 1988 after a 73-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 394 devices in its family, counting itself, has a Class I recall. 393 later devices descend from it.

Decided
Jan 4, 1988
Review
73 days
Class
Class II
Product code
HQO
Recalls
None
Predicates
0

393 later devices descend from it, 1 citing it directly. 1 of the 394 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 1998: 1 descendant cleared2001: 1 descendant cleared2002: 2 descendants cleared2004: 6 descendants cleared2008: 15 descendants cleared2006: 14 descendants cleared2007: 6 descendants cleared2011: 9 descendants cleared2003: 1 descendant cleared2005: 6 descendants cleared2009: 8 descendants cleared2014: 17 descendants cleared2010: 4 descendants cleared2018: 25 descendants cleared2025: 35 descendants cleared2024: 35 descendants cleared2017: 18 descendants cleared2022: 22 descendants cleared2013: 9 descendants cleared2012: 13 descendants cleared2019: 20 descendants cleared2016: 14 descendants cleared2020: 27 descendants cleared2021: 22 descendants cleared2015: 7 descendants cleared2023: 27 descendants cleared, 1 with a Class I recall12026: 29 descendants cleared1990200020102020
  1. This deviceK874367 Various Cardiac Cryoprobes Having Dia. & Cos. DiffSpembly Medical, Ltd. · 1988
  2. Descendant · cites it directly · 392 of its ownK974320 Cryogen Cardiac Cryosurgical SystemCryogen, Inc. · 1998
  3. Descendant · 2 generations on · 340 of its ownK013946 Flex 10 Accessory for the Afx Microwave Ablation SystemAfx, Inc. · 2002
  4. Descendant · 2 generations on · 268 of its ownK041340 Guidant Microwave Ablation SystemGuidant Corporation, Cardiac Surgery · 2004
  5. Descendant · 3 generations on · 251 of its ownK043153 Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc. · 2004
  6. Descendant · 4 generations on · 231 of its ownK050005 Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip…Intuitive Surgical, Inc. · 2005 · Recalled

Showing 5 of 393 descendants. See all descendants

Descendants cleared per year

1998: 12001: 12002: 22003: 12004: 62005: 62006: 142007: 62008: 152009: 82010: 42011: 92012: 132013: 92014: 172015: 72016: 142017: 182018: 252019: 202020: 272021: 222022: 222023: 272024: 352025: 352026: 29
1998high 35 (2024) · low 0 (1999)2026

Class I recalls in this family

  • K223095 Senhance Surgical System6 generations on · 2023

Most influential descendants

Showing 5 of 393 · See all
  • K974320Cryogen Cardiac Cryosurgical SystemCryogen, Inc. · 1998 · cites it directly392descendants
  • K013946Flex 10 Accessory for the Afx Microwave Ablation SystemAfx, Inc. · 2002 · 2 generations on340descendants
  • K041340Guidant Microwave Ablation SystemGuidant Corporation, Cardiac Surgery · 2004 · 2 generations on268descendants
  • K043153Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models IS1200 &…Intuitive Surgical, Inc. · 2004 · 3 generations on251descendants
  • K050005Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover Accessory, Model…Intuitive Surgical, Inc. · 2005 · 4 generations on231descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K874367Various Cardiac Cryoprobes Having Dia. & Cos. DiffSpembly Medical, Ltd.1988—
+1K974320Cryogen Cardiac Cryosurgical SystemCryogen, Inc.1998—
+2K013946Flex 10 Accessory for the Afx Microwave Ablation SystemAfx, Inc.2002—
+2K041340Guidant Microwave Ablation SystemGuidant Corporation, Cardiac Surgery2004—
+3K043153Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models…Intuitive Surgical, Inc.2004—
+4K050005Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover…Intuitive Surgical, Inc.20052

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200110
200220
200310
200460
200560
2006140
200760
2008150
200980
201040
201190
2012130
201390
2014170
201570
2016140
2017180
2018250
2019200
2020270
2021220
2022220
2023271
2024350
2025350
2026290
FIG. 1 — Lineage of K874367, 1988–2026Source: 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.

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
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? (393)

See all 393

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K974320Cryogen Cardiac Cryosurgical SystemCryogen, Inc.1998392

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.

  • K223095Senhance Surgical SystemAsensus Surgical, Inc. · 2023 · 6 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K974320 (Cryogen, Inc., 1998) has gone furthest, with 392 descendants of its own.

How does its category compare?

All HQO devices

HQO Unit, Cautery, Thermal, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HQO

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HQO

Too few HQO 510(k)s in any year since 2007 to give a median.

Recalls per year · HQO

No recall names HQO since 2007.

Adverse event reports per year · HQO

101in 2025

2010: 132011: 302012: 292013: 402014: 552015: 422016: 562018: 172019: 732020: 442021: 562022: 532023: 482024: 662025: 101
2007high 101 (2025) · low 0 (2007)2025

MAUDE reports naming product code HQO, 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
20071—00
20080—00
20090—00
20100—013
20110—030
20120—029
20130—040
20140—055
20150—042
20160—056
20170—00
20180—017
20190—073
20200—044
20210—056
20220—053
20230—048
20240—066
20250—0101
20260—0—

More from Spembly Medical, Ltd.

17 FDA decisions under this applicant name. See the company

  • K925129SelectorSpembly Medical, Ltd. · 1993
  • K903303Spembly Medical 242 Cryounit/Series 242 CryoprobesSpembly Medical, Ltd. · 1990
  • K901974Selector Ultrasonic Surgical AspiratorSpembly Medical, Ltd. · 1990
  • K882568130 Cryo Unit & Assoc. Cryoprobes & SpraySpembly Medical, Ltd. · 1988
  • K882962Series 40 & Series 42 Cryoprobes (R Series)Spembly Medical, Ltd. · 1988

Recent decisions in HQO

The HQO category page

  • K070871Starion Universal Power SupplyStarion Instruments · 2007
  • K043155Starion Universal Power Supply (Ups)Starion Instruments · 2004
  • K002341Thermal Cautery Unit, Model 150Geiger Medical Technologies, Inc. · 2000
  • K000893AC Powered Thermal Cautery UnitStarion Instruments · 2000
  • K971538Mentor Gemini Hemostatic EraserMentor Ophthalmics, Inc. · 1997

https://510kreport.com/device/K874367 · printed Nov 6, 2026

Cite this page

510(k) Report. “K874367: Various Cardiac Cryoprobes Having Dia. & Cos. Diff.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K874367

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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