510(k) Report

510(k) · Cleared

Cleared

Northrup Universal Annuloplasty System, Model 1000

K033685510(k) TraditionalCleared Aug 3, 2004253-day reviewClass II21 CFR 870.3800

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

Medical Cv, Inc. · KRH Ring, Annuloplasty

Cleared on Aug 3, 2004 as substantially equivalent to K992056 (Sulzer Carbomedics, Inc., 1999) and 2 other predicates after a 253-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it.

Decided
Aug 3, 2004
Review
253 days
Class
Class II
Product code
KRH
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K923367 (1993). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1999: 1 other ancestor1993: 1 other ancestor2007: 1 descendant clearedK923367 · Cosgrove Edwards Annuloplasty System, Model 4600 · Baxter Healthcare Corp · 19931990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 1 descendant K923367 · Cosgrove Edwards Annuloplasty System, Model 4600 · Baxter Healthcare Corp · 19930
  1. Root · 1 generation backK923367 Cosgrove Edwards Annuloplasty System, Model 4600Baxter Healthcare Corp · 1993
  2. This deviceK033685 Northrup Universal Annuloplasty System, Model 1000Medical Cv, Inc. · 2004
  3. Descendant · cites it directly · 0 of its ownK071281 Uniring - Annuloplasty Ring with SizersPeters Surgical · 2007

Most influential descendants

Showing 1 of 1 · See all
  • K071281Uniring - Annuloplasty Ring with SizersPeters Surgical · 2007 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K923367Cosgrove Edwards Annuloplasty System, Model 4600Baxter Healthcare Corp1993—
0 (this device)K033685Northrup Universal Annuloplasty System, Model 1000Medical Cv, Inc.2004—
+1K071281Uniring - Annuloplasty Ring with SizersPeters Surgical2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
199910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
FIG. 1 — Lineage of K033685, 1993–2007Source: 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 KRH? 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 KRH device

  1. #1 K261707 MEMO 4D Curve™ Semirigid mitral annuloplasty…score 12.7 · 5 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
*K992056Annuloflex Annuloplasty System, Model AF800
Summary page 1
…of this submission, the Northrup Universal Annuloplasty System was compared to the following predicate device(s): * CarboMedics AnnuloFlex Annuloplasty System - K992056 - can be implanted either as a partial or complete ring with identical function as the Northrup Uni…
Sulzer Carbomedics, Inc.1999—
*K923367Cosgrove Edwards Annuloplasty System, Model 4600
Summary page 1
…complete ring with identical function as the Northrup Universal Annuloplasty System • Edwards Lifesciences Cosgrove-Edwards Annuloplasty System - K923367 * Baxter Carpentier-Edwards Phvsio Annuloplasty Ring - K926138 Testing: The results of biocom…
Baxter Healthcare Corp1993—
*K926138Carpentier-Edwards Physio Annuloplasty Ring
Summary page 1
…Universal Annuloplasty System • Edwards Lifesciences Cosgrove-Edwards Annuloplasty System - K923367 * Baxter Carpentier-Edwards Phvsio Annuloplasty Ring - K926138 Testing: The results of biocompatibility testing support that the materials used in the manufacture…
Baxter Healthcare Corp1993—

Also cleared against K992056: 1 other device →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K071281Uniring - Annuloplasty Ring with SizersPeters Surgical20070

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 3 ancestors has a recall.
  • Of its descendants, K071281 (Peters Surgical, 2007) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K992056.

How does its category compare?

All KRH devices

KRH Ring, Annuloplasty: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KRH

4in 2025

2007: 42008: 22009: 82010: 22011: 22014: 12016: 12018: 22019: 22020: 22023: 22024: 12025: 42026 (partial year): 2
2007high 8 (2009) · low 0 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KRH

98in 2025

2007: 90 days median2009: 68 days median2025: 98 days median
2007high 98 (2025) · low 68 (2009)2026

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

Recalls per year · KRH

No recall names KRH since 2007.

Adverse event reports per year · KRH

420in 2025

2007: 2612008: 1,2882009: 9732010: 6302011: 3212012: 902013: 972014: 732015: 1452016: 3472017: 3792018: 3782019: 3492020: 3402021: 4232022: 3722023: 3242024: 4072025: 420
2007high 1,288 (2008) · low 73 (2014)2025

MAUDE reports naming product code KRH, 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
20074900261
20082—01,288
20098680973
20102—0630
20112—0321
20120—090
20130—097
20141—073
20150—0145
20161—0347
20170—0379
20182—0378
20192—0349
20202—0340
20210—0423
20220—0372
20232—0324
20241—0407
20254980420
20262—0—

What is it indicated for?

The MedicalCV, Inc. Northrup Universal Annuloplasty System is indicated as a reinforcement for repair of the human cardiac mitral or tricuspid valves damaged by acquired or congenital disease, or as a replacement for a previously implanted annuloplasty ring. The annuloplasty ring should be used only in cases where visual inspection confirms that the valve is repairable and does not require replacement.

Indications for use as stated in the FDA summary.

Also cleared against K992056

1 other device cites the same predicate.

  • K071281Uniring - Annuloplasty Ring with SizersPeters Surgical · 2007

More from Medical Cv, Inc.

14 FDA decisions under this applicant name. See the company

  • K081457Atrilaze Laser Ablation SystemMedical Cv, Inc. · 2008
  • K061489Atrilaze MI Surgical Ablation SystemMedical Cv, Inc. · 2007
  • K060680Atrilaze Surgical Ablation SystemMedical Cv, Inc. · 2006
  • K052495Atrilaze Malleable Ablation ProbeMedical Cv, Inc. · 2005
  • K040744Atrilaze Soft Tissue Ablation SystemMedical Cv, Inc. · 2004

Recent decisions in KRH

The KRH category page

  • K261707MEMO 4D Curve™ Semirigid mitral annuloplasty ringCorcym S.r.l. · 2026
  • K260498TriMemo™ SEMIRIGID ANNULOPLASTY RINGCorcym S.r.l. · 2026
  • K253232Seguin Annuloplasty RingAbbott Medical · 2025
  • K251982Edwards MC3 Tricuspid annuloplasty ring (4900)Edwards Lifesciences, LLC · 2025
  • K251688Carpentier-Edwards Physio Annuloplasty Ring (4450)Edwards Lifesciences, LLC · 2025

https://510kreport.com/device/K033685 · printed Nov 3, 2026

Cite this page

510(k) Report. “K033685: Northrup Universal Annuloplasty System, Model 1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033685

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