510(k) Report

510(k) · Cleared

Cleared

Biovalve Insulin Delivery Systems (Bids)

K050971510(k) TraditionalCleared Aug 16, 2005120-day reviewClass II21 CFR 880.5725

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

Biovalve Technologies, Inc. · LZG Pump, Infusion, Insulin

Cleared on Aug 16, 2005 as substantially equivalent to K031373 (Insulet Corp., 2003) after a 120-day review. Its family tree reaches back 1 generation to 2003. 10 later devices descend from it.

Decided
Aug 16, 2005
Review
120 days
Class
Class II
Product code
LZG
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K031373 (2003). 10 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2010: 3 descendants cleared2012: 1 descendant cleared2024: 2 descendants cleared2011: 1 descendant cleared2023: 1 descendant cleared2017: 1 descendant cleared2026: 1 descendant clearedK031373 · Ixl Diabetes Management System · Insulet Corp. · 2003200020052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 4 descendants3 generations forward: 4 descendants K031373 · Ixl Diabetes Management System · Insulet Corp. · 20030
  1. Root · 1 generation backK031373 Ixl Diabetes Management SystemInsulet Corp. · 2003
  2. This deviceK050971 Biovalve Insulin Delivery Systems (Bids)Biovalve Technologies, Inc. · 2005
  3. Descendant · cites it directly · 6 of its ownK093065 Finesse Personal Insulin Delivery Patch, Model FG-2000Calibra Medical, Inc. · 2010
  4. Descendant · 2 generations on · 5 of its ownK100947 Finesse Personal Insulin Delivery Patch, Model FG 2000Calibra Medical, Inc. · 2010
  5. Descendant · 2 generations on · 4 of its ownK111924 Finesse Personal Insulin Delivery PatchCalibra Medical, Inc. · 2012
  6. Descendant · 3 generations on · 3 of its ownK163357 OneTouch Via On-Demand Insulin Delivery SystemLifescan Europe, A Division of Cilag GmbH · 2017
  7. Descendant · 3 generations on · 2 of its ownK233447 CeQur Simplicity™ On-Demand Insulin Delivery SystemCequr SA · 2024

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2010: 32011: 12012: 12017: 12023: 12024: 22026: 1
2010high 3 (2010) · low 0 (2013)2026

Most influential descendants

Showing 5 of 10 · See all
  • K093065Finesse Personal Insulin Delivery Patch, Model FG-2000Calibra Medical, Inc. · 2010 · cites it directly6descendants
  • K100947Finesse Personal Insulin Delivery Patch, Model FG 2000Calibra Medical, Inc. · 2010 · 2 generations on5descendants
  • K111924Finesse Personal Insulin Delivery PatchCalibra Medical, Inc. · 2012 · 2 generations on4descendants
  • K163357OneTouch Via On-Demand Insulin Delivery SystemLifescan Europe, A Division of Cilag GmbH · 2017 · 3 generations on3descendants
  • K233447CeQur Simplicity™ On-Demand Insulin Delivery SystemCequr SA · 2024 · 3 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K031373Ixl Diabetes Management SystemInsulet Corp.2003—
0 (this device)K050971Biovalve Insulin Delivery Systems (Bids)Biovalve Technologies, Inc.2005—
+1K093065Finesse Personal Insulin Delivery Patch, Model FG-2000Calibra Medical, Inc.2010—
+2K100947Finesse Personal Insulin Delivery Patch, Model FG 2000Calibra Medical, Inc.2010—
+2K111924Finesse Personal Insulin Delivery PatchCalibra Medical, Inc.2012—
+3K163357OneTouch Via On-Demand Insulin Delivery SystemLifescan Europe, A Division of Cilag GmbH2017—
+3K233447CeQur Simplicity™ On-Demand Insulin Delivery SystemCequr SA2024—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201030
201110
201210
201710
202310
202420
202610
FIG. 1 — Lineage of K050971, 2003–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LZG? 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 16.8 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K031373Ixl Diabetes Management System
Summary page 1
…9.7Substantial Equivalence The BioValve Insulin Delivery Systems (BIDS) is substantially equivalent to the Insulet iXL Diabetes Management System (K031 373) as well as other Insulin Infusion Pumps and Subcutaneous Insulin Infusion Sets. 9.8Technological Characteristics…
Insulet Corp.2003—

Also cleared against K031373: 2 other devices →

What descends from it? (10)

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

NumberDeviceApplicantDecidedDescendants
K093065Finesse Personal Insulin Delivery Patch, Model FG-2000Calibra Medical, Inc.20106
K100504V-GO Disposable Insulin Delivery Device, Model# V-GO 20, V-GO 30, V-GO40Valeritas, LLC20102

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?

  • Its one ancestor has no recall.
  • Of its descendants, K093065 (Calibra Medical, Inc., 2010) has gone furthest, with 6 descendants of its own.
  • 2 other devices also cite its predicate K031373.

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)—

What is it indicated for?

The BioValve Insulin Delivery System (BIDS) is indicated for the continuous delivery of insulin,

at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.

Indications for use as stated in the FDA summary.

Also cleared against K031373

2 other devices cite the same predicate.

  • K093364Solo Micropump Insulin Delivery SystemMedingo, Ltd. · 2010
  • K090245Solo Insulin Patch PumpMedingo, Ltd. · 2009

More from Biovalve Technologies, Inc.

3 FDA decisions under this applicant name. See the company

  • K051985Biovalve Mini-Ject Needlefree InjectorBiovalve Technologies, Inc. · 2005
  • K032976Biovalve Miniject Needle-Free Injection System, Model FG-01-001Biovalve Technologies, Inc. · 2004

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/K050971 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050971: Biovalve Insulin Delivery Systems (Bids).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050971

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026