510(k) Report

510(k) · Decided

Decided

Retro Repair Kit, Model PRRK5

K022644510(k) TraditionalDecided Nov 6, 200290-day reviewClass II21 CFR 876.5540

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

Spire Biomedical, Inc. · NFK Kit, Repair, Catheter, Hemodialysis

Cleared on Nov 6, 2002 as substantially equivalent to K022000 (Spire Biomedical, Inc., 2002) and 2 other predicates after a 90-day review. Its family tree reaches back 3 generations to 2002. 1 later device descends from it.

Decided
Nov 6, 2002
Review
90 days
Class
Class II
Product code
NFK
Recalls
None
Predicates
3

Its longest line of descent runs back 3 generations to K013160 (2002). 5 ancestors in all, the oldest K002902 (2001). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 2 other ancestors2006: 1 descendant cleared×3: 3 generations cleared close together, K013160 (2002), K021212 (2002), K022000 (2002) 200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 1 descendant K022000 · Pourchez Retro Twin Lumen Chronic Hemodialysis Catheter with Separated Tips (with and Without Side Holes) · Spire Biomedical, Inc. · 2002K021212 · 24CM Pourchez Xpresso Twin Lumen Chronic Hemodialysis Catheter with Separated Tips · Spire Biomedical, Inc. · 2002K013160 · Pourchez Xpresso Twin Limen Chronic Hemodialysis Catheter · Spire Biomedical, Inc. · 20020
  1. Root · 3 generations backK013160 Pourchez Xpresso Twin Limen Chronic Hemodialysis CatheterSpire Biomedical, Inc. · 2002
  2. 2 generations backK021212 24CM Pourchez Xpresso Twin Lumen Chronic Hemodialysis Catheter with…Spire Biomedical, Inc. · 2002
  3. 1 generation backK022000 Pourchez Retro Twin Lumen Chronic Hemodialysis Catheter with…Spire Biomedical, Inc. · 2002
  4. This deviceK022644 Retro Repair Kit, Model PRRK5Spire Biomedical, Inc. · 2002
  5. Descendant · cites it directly · 0 of its ownK062435 Repair Kit for Xpresso, Decathlon, and Alta LR CathetersSpire Biomedical, Inc. · 2006

Most influential descendants

Showing 1 of 1 · See all
  • K062435Repair Kit for Xpresso, Decathlon, and Alta LR CathetersSpire Biomedical, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K013160Pourchez Xpresso Twin Limen Chronic Hemodialysis CatheterSpire Biomedical, Inc.2002—
−2K02121224CM Pourchez Xpresso Twin Lumen Chronic Hemodialysis Catheter with Separated…Spire Biomedical, Inc.2002—
−1K022000Pourchez Retro Twin Lumen Chronic Hemodialysis Catheter with Separated Tips…Spire Biomedical, Inc.2002—
0 (this device)K022644Retro Repair Kit, Model PRRK5Spire Biomedical, Inc.2002—
+1K062435Repair Kit for Xpresso, Decathlon, and Alta LR CathetersSpire Biomedical, Inc.2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200120

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
FIG. 1 — Lineage of K022644, 2002–2006Source: 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 NFK? 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
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
*K022000Pourchez Retro Twin Lumen Chronic Hemodialysis Catheter with Separated Tips (with and…
Summary page 1
…alence is Ciaimed: 1) Spire Biomedical, Inc. Pourchez RetrO Twin Lumen Silicone Chronic Hernodialysis Catheter with Separated Tips (extension adapters only) “K022000.” 2) Kendall Tandem-CathrM (in design and intended use) “K002900 3) Bard Access Systems, Inc. Catheter Repair Kit with Replac…
Spire Biomedical, Inc.2002—
*K002902Tandem-Cath 10 FR. Catheter System, Model Multiple Code Numbers
Our reading of the summary gave K002900, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Kendall Tandem-Cath”.
The Kendall Company20015
*K011015Catheter Repair Kit with Replacement Connector, Model 5587000C.R. Bard, Inc.2001—

Also cleared against K022000: 4 other devices →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K062435Repair Kit for Xpresso, Decathlon, and Alta LR CathetersSpire Biomedical, Inc.20060

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 0 years and passes through 1 company; a new generation was cleared every 2 months on median.
  • 1 of the 5 ancestors has a recall of any class.
  • Of its descendants, K062435 (Spire Biomedical, Inc., 2006) has gone furthest, with 0 descendants of its own.
  • 4 other devices also cite its predicate K022000.

How does its category compare?

All NFK devices

NFK Kit, Repair, Catheter, Hemodialysis: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NFK

1in 2010

2009: 12010: 1
2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NFK

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

Recalls per year · NFK

No recall names NFK since 2007.

Adverse event reports per year · NFK

18in 2025

2007: 12009: 22010: 32011: 162012: 112013: 162014: 12015: 12016: 72017: 82018: 52019: 52020: 12022: 182023: 42024: 192025: 18
2007high 19 (2024) · low 0 (2008)2025

MAUDE reports naming product code NFK, 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—01
20080—00
20091—02
20101—03
20110—016
20120—011
20130—016
20140—01
20150—01
20160—07
20170—08
20180—05
20190—05
20200—01
20210—00
20220—018
20230—04
20240—019
20250—018
20260—0—

What is it indicated for?

Pourchez RetrO Repair Kit is designed to replace worn or damaged extension connector adapters on Spire Biomedical, Inc.’s Pourchez RetrO catheters.

Indications for use as stated in the FDA summary.

Also cleared against K022000

4 other devices cite the same predicate.

  • K060288Retro Silver and Xpresso Silver Chronic Hemodialysis CathetersSpire Biomedical, Inc. · 2006
  • K043292HemocathMed-Conduit, Inc. · 2005
  • K04155955CM Pourchez Retro Safe Trac Twin Lumen Hemodialysis Catheter Model #RS50SH55,RS50NH55,RE50SH55 & RE50NH55Spire Biomedical, Inc. · 2004
  • K022620Sheathless Accessory Kit, Models XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 and XrikrtSpire Biomedical, Inc. · 2002

More from Spire Biomedical, Inc.

16 FDA decisions under this applicant name. See the company

  • K073092Decathlon Twin Lumen Hemodialysis Catheter with Separated Tips, Models DE19SH24, DE23SH28, DE27SH32…Spire Biomedical, Inc. · 2008
  • K073093Decathlon Gold Twin Lumen Hemodialysis Catheter with Separated Tips, Models DEC19SH24, DEC23SH28, DEC23SH32…Spire Biomedical, Inc. · 2008
  • K06344115.5FR Alta Gold, Coated Hemodialysis Catheter, Model ALC19SH24, ALC23SH28, ALC27SH32, ALC31SH36, ALC35SH40…Spire Biomedical, Inc. · 200748 recalls
  • K06343115.5 FR Decathlon Gold, Funnel Tips, Coated Hemodialysis Catheter, DFC19SH24, DFC23SH28, DFC27SH32…Spire Biomedical, Inc. · 200748 recalls
  • K062435Repair Kit for Xpresso, Decathlon, and Alta LR CathetersSpire Biomedical, Inc. · 2006

Recent decisions in NFK

The NFK category page

  • K101261Catheter Repair Kit with Replacement Connector, Model 5587000C.R. Bard, Inc. · 2010
  • K092797Acute and Chronic Catheter Repair KitKendall · 20091 recall
  • K063446Catheter Repair Kit with Replacement Connector, Model 5587000C.R. Bard, Inc. · 2006
  • K062435Repair Kit for Xpresso, Decathlon, and Alta LR CathetersSpire Biomedical, Inc. · 2006
  • K030442Catheter Repair Kit with Replacement Connector, Model 5587000C.R. Bard, Inc. · 2003

https://510kreport.com/device/K022644 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022644: Retro Repair Kit, Model PRRK5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022644

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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