510(k) Report

510(k) · Cleared

Cleared

Gambro Bicarbonate Module, BCM-10

K810127510(k) TraditionalCleared Feb 25, 198137-day reviewClass II21 CFR 876.5820

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

Gambro, Inc. · FKR Subsystem, Proportioning

Cleared on Feb 25, 1981 after a 37-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.

Decided
Feb 25, 1981
Review
37 days
Class
Class II
Product code
FKR
Recalls
None
Predicates
0

6 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared2008: 2 descendants cleared2006: 1 descendant cleared2011: 1 descendant cleared2014: 1 descendant cleared19801990200020102020
  1. This deviceK810127 Gambro Bicarbonate Module, BCM-10Gambro, Inc. · 1981
  2. Descendant · cites it directly · 5 of its ownK043436 Nxstage Dialysate Preparation Module, Model NX0269Nxstage Medical, Inc. · 2005
  3. Descendant · 2 generations on · 3 of its ownK060296 Nxstage Dialysate Preparation ModuleNxstage Medical, Inc. · 2006
  4. Descendant · 3 generations on · 2 of its ownK080919 Nxstage Pureflow SLNxstage Medical, Inc. · 2008 · Recalled
  5. Descendant · 4 generations on · 1 of its ownK111174 Nxstage Pureflow SLNxstage Medical, Inc. · 2011 · Recalled
  6. Descendant · 5 generations on · 0 of its ownK140571 Nxstage Pureflow SLNxstage Medical, Inc. · 2014 · Recalled

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2005: 12006: 12008: 22011: 12014: 1
2005high 2 (2008) · low 0 (2007)2026

Most influential descendants

Showing 5 of 6 · See all
  • K043436Nxstage Dialysate Preparation Module, Model NX0269Nxstage Medical, Inc. · 2005 · cites it directly5descendants
  • K060296Nxstage Dialysate Preparation ModuleNxstage Medical, Inc. · 2006 · 2 generations on3descendants
  • K080919Nxstage Pureflow SLNxstage Medical, Inc. · 2008 · 3 generations on2descendants
  • K111174Nxstage Pureflow SLNxstage Medical, Inc. · 2011 · 4 generations on1descendant
  • K140571Nxstage Pureflow SLNxstage Medical, Inc. · 2014 · 5 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K810127Gambro Bicarbonate Module, BCM-10Gambro, Inc.1981—
+1K043436Nxstage Dialysate Preparation Module, Model NX0269Nxstage Medical, Inc.2005—
+2K060296Nxstage Dialysate Preparation ModuleNxstage Medical, Inc.2006—
+3K080919Nxstage Pureflow SLNxstage Medical, Inc.20081
+4K111174Nxstage Pureflow SLNxstage Medical, Inc.20119
+5K140571Nxstage Pureflow SLNxstage Medical, Inc.20149

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200610
200820
201110
201410
FIG. 1 — Lineage of K810127, 1981–2014Source: 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 FKR? 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
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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? (6)

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

NumberDeviceApplicantDecidedDescendants
K043436Nxstage Dialysate Preparation Module, Model NX0269Nxstage Medical, Inc.20055

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?

  • Of its descendants, K043436 (Nxstage Medical, Inc., 2005) has gone furthest, with 5 descendants of its own.

How does its category compare?

All FKR devices

FKR Subsystem, Proportioning: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FKR

1in 2014

2008: 12011: 12014: 1
2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FKR

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

Recalls per year · FKR

1in 2018

2011: 12018: 1
2007high 1 (2011) · low 0 (2007)2026

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

Adverse event reports per year · FKR

4in 2025

2014: 12017: 22018: 22019: 32022: 32023: 22025: 4
2007high 4 (2025) · low 0 (2007)2025

MAUDE reports naming product code FKR, 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
20070—00
20081—00
20090—00
20100—00
20111—10
20120—00
20130—00
20141—01
20150—00
20160—00
20170—02
20180—12
20190—03
20200—00
20210—00
20220—03
20230—02
20240—00
20250—04
20260—0—

More from Gambro, Inc.

86 FDA decisions under this applicant name. See the company

  • K083158Exalis, Software Version 1.15Gambro, Inc. · 2009
  • K070643Phoenix Hemodialysis Delivery System, Version 3.35Gambro, Inc. · 2007
  • K032431Prisma M60/M100 SetsGambro, Inc. · 20036 recalls
  • K896758Gambro Bicarbonate Monitor BCM 10-3Gambro, Inc. · 1990
  • K896757Gambro AK-10 Dialysis System for High FlowsGambro, Inc. · 1990

Recent decisions in FKR

The FKR category page

  • K140571Nxstage Pureflow SLNxstage Medical, Inc. · 20149 recalls
  • K111174Nxstage Pureflow SLNxstage Medical, Inc. · 20119 recalls
  • K080919Nxstage Pureflow SLNxstage Medical, Inc. · 20081 recall
  • K060296Nxstage Dialysate Preparation ModuleNxstage Medical, Inc. · 2006
  • K043436Nxstage Dialysate Preparation Module, Model NX0269Nxstage Medical, Inc. · 2005

https://510kreport.com/device/K810127 · printed Nov 5, 2026

Cite this page

510(k) Report. “K810127: Gambro Bicarbonate Module, BCM-10.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K810127

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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