510(k) Report

510(k) · Cleared

Cleared

Rapido Hollow-Fibre Dialyzers

K160558510(k) TraditionalCleared Nov 18, 2016263-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

Bellco Srl · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

Cleared on Nov 18, 2016 as substantially equivalent to K062079 (Baxter Healthcare Corporation, 2006) and 2 other predicates after a 263-day review. Its family tree reaches back 7 generations to 2001.

Decided
Nov 18, 2016
Review
263 days
Class
Class II
Product code
KDI
Recalls
None
Predicates
3

Its longest line of descent runs back 7 generations to K001283 (2001). 22 ancestors in all, the oldest K872364 (1987). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2005: 1 other ancestor2001: 1 other ancestor2003: 2 other ancestors1990: 2 other ancestors1999: 1 other ancestor1998: 2 other ancestors1994: 1 other ancestor1989: 1 other ancestor1997: 2 other ancestors1987: 1 other ancestor1991: 1 other ancestorK001283 · Lifemate Hemofiltration System · Nxstage Medical, Inc. · 2001K012510 · Modification to: Lifemate Hemofiltration System · Nxstage Medical, Inc. · 2001K020858 · Nxstage Therapy System · Nxstage Medical, Inc. · 2002K030470 · Nxstage System One · Nxstage Medical, Inc. · 2003K041424 · Nxstage System One · Nxstage Medical, Inc. · 2004K050525 · Nxstage System One · Nxstage Medical, Inc. · 2005 · recalledK062079 · Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210 · Baxter Healthcare Corporation · 20061985199019952000200520102015
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 3 other ancestors3 generations back: 5 other ancestors4 generations back: 1 other ancestor5 generations back: 2 other ancestors6 generations back: 2 other ancestors K062079 · Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210 · Baxter Healthcare Corporation · 2006K050525 · Nxstage System One · Nxstage Medical, Inc. · 2005 · recalledK041424 · Nxstage System One · Nxstage Medical, Inc. · 2004K030470 · Nxstage System One · Nxstage Medical, Inc. · 2003K020858 · Nxstage Therapy System · Nxstage Medical, Inc. · 2002K012510 · Modification to: Lifemate Hemofiltration System · Nxstage Medical, Inc. · 2001K001283 · Lifemate Hemofiltration System · Nxstage Medical, Inc. · 2001−50
  1. Root · 7 generations backK001283 Lifemate Hemofiltration SystemNxstage Medical, Inc. · 2001
  2. 6 generations backK012510 Modification to: Lifemate Hemofiltration SystemNxstage Medical, Inc. · 2001
  3. 5 generations backK020858 Nxstage Therapy SystemNxstage Medical, Inc. · 2002
  4. 4 generations backK030470 Nxstage System OneNxstage Medical, Inc. · 2003
  5. 3 generations backK041424 Nxstage System OneNxstage Medical, Inc. · 2004
  6. 2 generations backK050525 Nxstage System OneNxstage Medical, Inc. · 2005 · Recalled
  7. 1 generation backK062079 Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210Baxter Healthcare Corporation · 2006
  8. This deviceK160558 Rapido Hollow-Fibre DialyzersBellco Srl · 2016
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K001283Lifemate Hemofiltration SystemNxstage Medical, Inc.2001—
−6K012510Modification to: Lifemate Hemofiltration SystemNxstage Medical, Inc.2001—
−5K020858Nxstage Therapy SystemNxstage Medical, Inc.2002—
−4K030470Nxstage System OneNxstage Medical, Inc.2003—
−3K041424Nxstage System OneNxstage Medical, Inc.2004—
−2K050525Nxstage System OneNxstage Medical, Inc.20052
−1K062079Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210Baxter Healthcare Corporation2006—
0 (this device)K160558Rapido Hollow-Fibre DialyzersBellco Srl2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
198910
199020
199110
199410
199720
199820
199910
200110
200320
200510
FIG. 1 — Lineage of K160558, 2001–2016Source: 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 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
Get a 510(k) Report

What was it cleared against? (3)

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
*K062079Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210
Summary page 4
…OMMON NAME: hemofilter/dialyzer CLASSIFICATION NAME: High Permeability Hemodialysis System, 21 CFR 876.5860 PREDICATE DEVICE(S): Xenium Dialyzer, Models 190 and 210 (K062079) Syntra 120, 160 (K002210) and the Polyflux6H (K051520) DEVICE DESCRIPTION: The above mentioned devices are dialyzers consistin…
Baxter Healthcare Corporation2006—
*K002210Syntra Dialyzer, Model Syntra 120, 160
Summary page 4
…lyzer CLASSIFICATION NAME: High Permeability Hemodialysis System, 21 CFR 876.5860 PREDICATE DEVICE(S): Xenium Dialyzer, Models 190 and 210 (K062079) Syntra 120, 160 (K002210) and the Polyflux6H (K051520) DEVICE DESCRIPTION: The above mentioned devices are dialyzers consisting of a cylindrical polycar…
Baxter Healthcare Corp2001—
*K051520Gambro Polyflux Hemodialyzer, Model 6H
Summary page 4
…igh Permeability Hemodialysis System, 21 CFR 876.5860 PREDICATE DEVICE(S): Xenium Dialyzer, Models 190 and 210 (K062079) Syntra 120, 160 (K002210) and the Polyflux6H (K051520) DEVICE DESCRIPTION: The above mentioned devices are dialyzers consisting of a cylindrical polycarbonate transparent body conta…
Gambro Renal Products2005—

Also cleared against K062079: 5 other devices →

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?

  • The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 12 months on median.
  • 2 of the 22 ancestors have a recall of any class.
  • 5 other devices also cite its predicate K062079.

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. 2016, this device’s year, is highlighted.

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 800 series RAPIDO BLS HOLLOW-FIBRE DIALYZERS are single-use devices intended for hemodialysis (HD), hemofiltration (HF), and hemodiafiltration (HDF) to treat conditions of acute or chronic renal failure when conservative therapy is judged to be inadequate. They are also indicated in the treatment of patients intoxicated with poisons or drugs.

Indications for use as stated in the FDA summary.

Also cleared against K062079

5 other devices cite the same predicate.

  • K131050Nxstage 1.6M2 DialyzerNxstage Medical, Inc. · 2013
  • K122952Nipro Pureflux-L HemodialyzerNipro Medical Corporation · 2013
  • K122343Pureflux-H HemodialyzerNipro Medical Corporation · 2013
  • K083778Xenium XPH, Models 110, 130, 150, 170, 190 and 210Baxter Healthcare Corporation · 2009
  • K082414Optiflux F250NR, Model 0500325EFresenius Medical Care North America · 20083 recalls

More from Bellco Srl

3 FDA decisions under this applicant name. See the company

  • K231406ClearumTM HSBellco Srl · 2023
  • K193542Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22Bellco Srl · 2020

Recent decisions in KDI

The KDI category page

  • K261203multiFiltratePRO SystemFresenius Medical Care Renal Therapies Group, LLC · 2026
  • K261267Careflux H60;Careflux H70;Careflux V500Fresenius Medical Care Renal Therapies Group, LLC · 2026
  • K252377NxStage System One with NxViewFresenius Medical Care Renal Therapies Group, LLC · 2026
  • K260533Elisio™-HNipro Medical Corporation · 2026
  • K252459multiFlux 130 (F00013123); multiFlux 160 (F00013124)Fresenius Medical Care Renal Therapies Group, LLC · 2026

https://510kreport.com/device/K160558 · printed Nov 6, 2026

Cite this page

510(k) Report. “K160558: Rapido Hollow-Fibre Dialyzers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160558

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