510(k) Report

510(k) · Cleared

Recalled · 2003

H-Tron V 100 Insulin Infusion Pump

K905693510(k) TraditionalCleared Apr 12, 1991114-day reviewClass II21 CFR 880.5725Recalls 1

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

Disetronic Medical Systems · LZG Pump, Infusion, Insulin

Cleared on Apr 12, 1991 after a 114-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 29 devices in its family, counting itself, has a Class I recall. 28 later devices descend from it. It has been recalled once.

Decided
Apr 12, 1991
Review
114 days
Class
Class II
Product code
LZG
Recalls
1
Predicates
0

28 later devices descend from it, 1 citing it directly. 1 of the 29 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 1997: 1 descendant cleared1999: 3 descendants cleared1998: 1 descendant cleared2002: 4 descendants cleared2005: 1 descendant cleared2007: 2 descendants cleared2009: 1 descendant cleared2011: 2 descendants cleared, 1 with a Class I recall12004: 1 descendant cleared2008: 1 descendant cleared2013: 1 descendant cleared2014: 3 descendants cleared2016: 3 descendants cleared2015: 1 descendant cleared2024: 1 descendant cleared2026: 2 descendants cleared1990200020102020
  1. This deviceK905693 H-Tron V 100 Insulin Infusion PumpDisetronic Medical Systems · 1991
  2. Descendant · cites it directly · 27 of its ownK973044 Disetronic H-Tron Plus V 100 Insulin Infusion PumpDisetronic Medical Systems · 1997 · Recalled
  3. Descendant · 2 generations on · 12 of its ownK013309 Glucopro Evo Infusion PumpNipro Diabetes Systems, Inc. · 2002 · Recalled
  4. Descendant · 3 generations on · 11 of its ownK050312 Amigo Insulin PumpNipro Diabetes Systems, Inc. · 2005
  5. Descendant · 4 generations on · 10 of its ownK071613 Amigo Insulin PumpNipro Diabetes Systems, Inc. · 2007
  6. Descendant · 5 generations on · 9 of its ownK111210 T:Slim (TM) Insulin Delivery SystemTandem Diabetes Care, Inc. · 2011 · Recalled (Class I)

Showing 5 of 28 descendants. See all descendants

Descendants cleared per year

1997: 11998: 11999: 32002: 42004: 12005: 12007: 22008: 12009: 12011: 22013: 12014: 32015: 12016: 32024: 12026: 2
1997high 4 (2002) · low 0 (2000)2026

Class I recalls in this family

  • K111210 T:Slim (TM) Insulin Delivery System5 generations on · 2011

Most influential descendants

Showing 5 of 28 · See all
  • K973044Disetronic H-Tron Plus V 100 Insulin Infusion PumpDisetronic Medical Systems · 1997 · cites it directly27descendants
  • K013309Glucopro Evo Infusion PumpNipro Diabetes Systems, Inc. · 2002 · 2 generations on12descendants
  • K050312Amigo Insulin PumpNipro Diabetes Systems, Inc. · 2005 · 3 generations on11descendants
  • K071613Amigo Insulin PumpNipro Diabetes Systems, Inc. · 2007 · 4 generations on10descendants
  • K111210T:Slim (TM) Insulin Delivery SystemTandem Diabetes Care, Inc. · 2011 · 5 generations on9descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K905693H-Tron V 100 Insulin Infusion PumpDisetronic Medical Systems1991—
+1K973044Disetronic H-Tron Plus V 100 Insulin Infusion PumpDisetronic Medical Systems19975
+2K013309Glucopro Evo Infusion PumpNipro Diabetes Systems, Inc.20021
+3K050312Amigo Insulin PumpNipro Diabetes Systems, Inc.2005—
+4K071613Amigo Insulin PumpNipro Diabetes Systems, Inc.2007—
+5K111210T:Slim (TM) Insulin Delivery SystemTandem Diabetes Care, Inc.2011Class I

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199810
199930
200240
200410
200510
200720
200810
200910
201121
201310
201430
201510
201630
202410
202620
FIG. 1 — Lineage of K905693, 1991–2026Source: 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.

Top candidate predicates for a new LZG device

  1. #1 K253534 Pivot Insulin Delivery Systemscore 16.9 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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? (28)

See all 28

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

NumberDeviceApplicantDecidedDescendants
K973044Disetronic H-Tron Plus V 100 Insulin Infusion PumpDisetronic Medical Systems199727

Has anything in its family been recalled? (1 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jul 21, 2003Not classifiedZ-1196-03OtherLack of assurance of reliability, due to quality system regulations violations, plus notice to users not to expose pump to water.

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.

  • K111210T:Slim (TM) Insulin Delivery SystemTandem Diabetes Care, Inc. · 2011 · 5 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K973044 (Disetronic Medical Systems, 1997) has gone furthest, with 27 descendants of its own.

How does its category compare?

All LZG devices

LZG Pump, Infusion, Insulin: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LZG

2in 2024

2007: 32008: 62009: 22010: 22011: 42012: 32013: 22014: 42015: 12016: 42017: 12018: 12019: 22021: 12022: 12023: 12024: 22026 (partial year): 2
2007high 6 (2008) · low 0 (2020)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LZG

116in 2016

2007: 112 days median2008: 129 days median2011: 189 days median2012: 73 days median2014: 123 days median2016: 116 days median
2007high 189 (2011) · low 73 (2012)2026

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

Recalls per year · LZG

1in 2022

2007: 12008: 132009: 22010: 42011: 22012: 42013: 3, 1 Class I2014: 2, 1 Class I2015: 2, 2 Class I2018: 3, 2 Class I2019: 52022: 1, 1 Class I2026 (partial year): 2, 2 Class I
2007high 13 (2008) · low 0 (2016)2026

Class I (9 since 2007) Class II/III not classified

Adverse event reports per year · LZG

12,004in 2025

2007: 5,1102008: 5,7112009: 9,4712010: 10,1752011: 12,8582012: 18,3672013: 30,0592014: 49,1882015: 69,1362016: 56,5812017: 44,4722018: 32,6522019: 29,0272020: 32,5882021: 31,5222022: 28,2252023: 21,9722024: 18,2282025: 12,004
2007high 69,136 (2015) · low 5,110 (2007)2025

MAUDE reports naming product code LZG, 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
2007311215,110
20086129135,711
20092—29,471
20102—410,175
20114189212,858
2012373418,367
20132—3 (1)30,059
201441232 (1)49,188
20151—2 (2)69,136
20164116056,581
20171—044,472
20181—3 (2)32,652
20192—529,027
20200—032,588
20211—031,522
20221—1 (1)28,225
20231—021,972
20242—018,228
20250—012,004
20262—2 (2)—

More from Disetronic Medical Systems

17 FDA decisions under this applicant name. See the company

  • K013782Disetronic Penfine Insulin Injection Pen NeedleDisetronic Medical Systems · 2001
  • K994186Disetronic D-Tron Insulin Infusion PumpDisetronic Medical Systems · 1999
  • K994197Disentronic Penfine Injection Pen NeedleDisetronic Medical Systems · 1999
  • K993666Disetronic Pen P100Disetronic Medical Systems · 1999
  • K991376Dahedi Insulin Infusion PumpDisetronic Medical Systems · 19991 recall

Recent decisions in LZG

The LZG category page

  • K262153Pivot Insulin Delivery SystemModular Medical, Inc. · 2026
  • K253534Pivot Insulin Delivery SystemModular Medical · 2026
  • K240158Modular Medical MODD1 Insulin Delivery SystemModular Medical, Inc. · 2024
  • K241622Extended Reservoir; MiniMed ReservoirMedtronic Minimed · 2024
  • K223372Omnipod GO Insulin Delivery DeviceInsulet Corporation · 2023

https://510kreport.com/device/K905693 · printed Nov 3, 2026

Cite this page

510(k) Report. “K905693: H-Tron V 100 Insulin Infusion Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K905693

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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