510(k) Report

510(k) · Cleared

Cleared

Rmi Hemoconcentrator Preference Pack

K970739510(k) TraditionalCleared Jul 8, 1997130-day reviewClass II21 CFR 876.5860

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

Research Medical, Inc. · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

Cleared on Jul 8, 1997 as substantially equivalent to K823338 (Cobe Laboratories, Inc., 1983) and 3 other predicates after a 130-day review. Its family tree reaches back 1 generation to 1983.

Decided
Jul 8, 1997
Review
130 days
Class
Class II
Product code
KDI
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K823338 (1983). 4 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1996: 1 other ancestor1995: 2 other ancestorsK823338 · Cobe Hemoconcentrator 1.3 · Cobe Laboratories, Inc. · 19831980198519901995
Other ancestors, by generation 1 generation back: 3 other ancestors K823338 · Cobe Hemoconcentrator 1.3 · Cobe Laboratories, Inc. · 19830
  1. Root · 1 generation backK823338 Cobe Hemoconcentrator 1.3Cobe Laboratories, Inc. · 1983
  2. This deviceK970739 Rmi Hemoconcentrator Preference PackResearch Medical, Inc. · 1997
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K823338Cobe Hemoconcentrator 1.3Cobe Laboratories, Inc.1983—
0 (this device)K970739Rmi Hemoconcentrator Preference PackResearch Medical, Inc.1997—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199520
199610
FIG. 1 — Lineage of K970739, 1983–1997Source: 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), 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 KDI? 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 KDI device

  1. #1 K243874 FX CorAL 60 (F00012969); FX CorAL 80…score 18.2 · 12 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? (7)

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
*K823338Cobe Hemoconcentrator 1.3
Summary page 1
…ence of the RMI Hemoconcentrator Preference Pack, or components thereof, is made to the: . COBE CV Personalized Hemoconcentration Packs, 510(k) number unknown [possibly K823338]; . COBE CV 3 Liter Waste Bag For Filtrate Collection, preamendment device; . COBE CV Hemoconcentrator, K823338; . Baxter Bentl…
Cobe Laboratories, Inc.1983—
*K945596Altres (R) 140 Hemodialyzer
Summary page 1
…Bag For Filtrate Collection, preamendment device; . COBE CV Hemoconcentrator, K823338; . Baxter Bentley HemoCon 1.3, 510(k) number unknown; . ALTREX® 140 Hemodialyzer, K945596; . RMI Hemoconcentrator, HEM-140, K951344; and . RMI Hemoconcentrator Tubing Set with adapters, TS-024, and Ultrafiltrate Waste…
Althin Medical AB an Affiliate of Baxter Intl1995—
*K951344Rmi Hemoconcentrator
Summary page 1
…evice; . COBE CV Hemoconcentrator, K823338; . Baxter Bentley HemoCon 1.3, 510(k) number unknown; . ALTREX® 140 Hemodialyzer, K945596; . RMI Hemoconcentrator, HEM-140, K951344; and . RMI Hemoconcentrator Tubing Set with adapters, TS-024, and Ultrafiltrate Waste Bag, WB-001, K961927. ’ These devices wer…
Research Medical, Inc.1995—
*K961927Rmi Hemoconcentractor Tubing Set
Summary page 1
…140 Hemodialyzer, K945596; . RMI Hemoconcentrator, HEM-140, K951344; and . RMI Hemoconcentrator Tubing Set with adapters, TS-024, and Ultrafiltrate Waste Bag, WB-001, K961927. ’ These devices were marketed prior to May 28, 1976 or have received FDA clearance to market since that date. L…
Research Medical, Inc.1996—
*—COBE CV Personalized Hemoconcentration Packs
Named without a submission number
—
*—COBE CV 3 Liter Waste Bag For Filtrate Collection
Named without a submission number
—
*—Baxter Bentley HemoCon 1.3
Named without a submission number
—

What descends from it?

No later submission names this one as a predicate yet.

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?

  • None of the 4 ancestors has a recall.

How does its category compare?

All KDI devices

KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KDI

9in 2025

2007: 112008: 62009: 42010: 92011: 52012: 62013: 112014: 82015: 52016: 52017: 82018: 22019: 42020: 92021: 22022: 72023: 72024: 72025: 92026 (partial year): 6
2007high 11 (2007) · low 2 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KDI

199in 2025

2007: 91 days median2008: 148 days median2009: 236 days median2010: 186 days median2011: 85 days median2012: 153 days median2013: 247 days median2014: 164 days median2015: 69 days median2016: 230 days median2017: 188 days median2019: 263 days median2020: 266 days median2022: 259 days median2023: 157 days median2024: 235 days median2025: 199 days median2026 (partial year): 154 days median
2007high 266 (2020) · low 69 (2015)2026

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

Recalls per year · KDI

2in 2025

2007: 42009: 32010: 12011: 42012: 12013: 22014: 32015: 52016: 42017: 12018: 12019: 62021: 22022: 172023: 8, 8 Class I2024: 4, 2 Class I2025: 22026 (partial year): 2
2007high 17 (2022) · low 0 (2008)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · KDI

2,786in 2025

2007: 9162008: 1,0422009: 5222010: 8232011: 2,2702012: 1,7652013: 2,3602014: 6,1542015: 4,1822016: 7662017: 9632018: 1,7162019: 1,5872020: 1,6332021: 1,9442022: 2,1802023: 2,6922024: 2,4412025: 2,786
2007high 6,154 (2014) · low 522 (2009)2025

MAUDE reports naming product code KDI, 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
200711914916
2008614801,042
200942363522
201091861823
201158542,270
2012615311,765
20131124722,360
2014816436,154
201556954,182
201652304766
201781881963
20182—11,716
2019426361,587
2020926601,633
20212—21,944
20227259172,180
202371578 (8)2,692
202472354 (2)2,441
2025919922,786
202661542—

What is it indicated for?

The hemoconcentrator is intended for relief or mitigation of overhydration in patients undergoing cardiopulmonary bypass procedures and to decrease the concentration of plasma water in blood.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Research Medical, Inc.

35 FDA decisions under this applicant name. See the company

  • K964833Rmi Dual Fluid Irrigating SyringeResearch Medical, Inc. · 1997
  • K961927Rmi Hemoconcentractor Tubing SetResearch Medical, Inc. · 1996
  • K960098Rmi Internal Mammary Artery CannulaResearch Medical, Inc. · 1996
  • K951344Rmi HemoconcentratorResearch Medical, Inc. · 1995
  • K922083Rmi Surgiccal Site Visualization WandResearch Medical, Inc. · 1993

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https://510kreport.com/device/K970739 · printed Nov 4, 2026

Cite this page

510(k) Report. “K970739: Rmi Hemoconcentrator Preference Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970739

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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