510(k) Report

510(k) · Cleared

Recalled · Class II · 2022

H/S Catheter Set (61-3005, 61-3007, 61-3605, 61-3607)

K961752510(k) TraditionalCleared Aug 8, 199694-day reviewClass II21 CFR 884.4530Recalls 2

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

Ackrad Laboratories · LKF Cannula, Manipulator/Injector, Uterine

Cleared on Aug 8, 1996 as substantially equivalent to K953034 (Ackrad Laboratories, 1995) after a 94-day review. Its family tree reaches back 1 generation to 1995. 6 later devices descend from it. It has been recalled 2 times.

Decided
Aug 8, 1996
Review
94 days
Class
Class II
Product code
LKF
Recalls
2
Predicates
1

Its longest line of descent runs back 1 generation to K953034 (1995). 6 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2001: 1 descendant cleared2002: 1 descendant cleared2009: 1 descendant cleared2007: 1 descendant cleared2018: 1 descendant cleared2022: 1 descendant clearedK953034 · H/S Catheter Set (61-3005, 61-3007, 61-3605, 61-3607) · Ackrad Laboratories · 19951995200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 1 descendant4 generations forward: 1 descendant K953034 · H/S Catheter Set (61-3005, 61-3007, 61-3605, 61-3607) · Ackrad Laboratories · 19950
  1. Root · 1 generation backK953034 H/S Catheter Set (61-3005, 61-3007, 61-3605, 61-3607)Ackrad Laboratories · 1995
  2. This deviceK961752 H/S Catheter Set (61-3005, 61-3007, 61-3605, 61-3607)Ackrad Laboratories · 1996
  3. Descendant · cites it directly · 5 of its ownK013972 H/S Elliptosphere Catheter Set, Model 61-4005Ackard Laboratories · 2001 · Recalled
  4. Descendant · 2 generations on · 2 of its ownK083594 EZ HSG Catheter.Foamseal CatheterObg Products · 2009
  5. Descendant · 3 generations on · 1 of its ownK180300 Margolin HSG Cannula, Goldstein Sonohysterography CatheterCook Incorporated · 2018
  6. Descendant · 4 generations on · 0 of its ownK222798 Rejoni Intrauterine CatheterRejoni, Inc. · 2022
  7. Descendant · 2 generations on · 0 of its ownK063611 Saline/ Contrast Media Infusion CatheterUtah Medical Products, Inc. · 2007

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2001: 12002: 12007: 12009: 12018: 12022: 1
2001high 1 (2001) · low 0 (2003)2026

Most influential descendants

Showing 5 of 6 · See all
  • K013972H/S Elliptosphere Catheter Set, Model 61-4005Ackard Laboratories · 2001 · cites it directly5descendants
  • K083594EZ HSG Catheter.Foamseal CatheterObg Products · 2009 · 2 generations on2descendants
  • K180300Margolin HSG Cannula, Goldstein Sonohysterography CatheterCook Incorporated · 2018 · 3 generations on1descendant
  • K222798Rejoni Intrauterine CatheterRejoni, Inc. · 2022 · 4 generations on0descendants
  • K063611Saline/ Contrast Media Infusion CatheterUtah Medical Products, Inc. · 2007 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K953034H/S Catheter Set (61-3005, 61-3007, 61-3605, 61-3607)Ackrad Laboratories1995—
0 (this device)K961752H/S Catheter Set (61-3005, 61-3007, 61-3605, 61-3607)Ackrad Laboratories1996—
+1K013972H/S Elliptosphere Catheter Set, Model 61-4005Ackard Laboratories20012
+2K083594EZ HSG Catheter.Foamseal CatheterObg Products2009—
+3K180300Margolin HSG Cannula, Goldstein Sonohysterography CatheterCook Incorporated2018—
+4K222798Rejoni Intrauterine CatheterRejoni, Inc.2022—
+2K063611Saline/ Contrast Media Infusion CatheterUtah Medical Products, Inc.2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200210
200710
200910
201810
202210
FIG. 1 — Lineage of K961752, 1995–2022Source: 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 LKF? 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 LKF device

  1. #1 K241693 FemChec Controlled Saline-Air Device (FCD-250)score 11.6 · 3 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? (1)

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
*K953034H/S Catheter Set (61-3005, 61-3007, 61-3605, 61-3607)
Summary page 1
…Contact person: Bernard Ackerman, Ph.D. Date: May 2, 1996 2. Device name Modified Hysterosalpingography Set 3. Predicate Device Modified Hysterosalpingography Set - K953034 4. Description of the device (See Exhibit 2) The Modified Hysterosalpingography Set consists of three parts: a double-lumen, bal…
Ackrad Laboratories1995—

Also cleared against K953034: 1 other device →

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K013972H/S Elliptosphere Catheter Set, Model 61-4005Ackard Laboratories20015

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
May 25, 2022Class IIZ-1613-2022Environmental controlFacility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
Mar 31, 2022Class IIZ-0502-2024Component design/selectionIncorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage may result in delay of procedure

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K013972 (Ackard Laboratories, 2001) has gone furthest, with 5 descendants of its own.
  • 1 other device also cites its predicate K953034.

How does its category compare?

All LKF devices

LKF Cannula, Manipulator/Injector, Uterine: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LKF

2in 2025

2007: 32009: 22010: 62011: 32013: 32014: 32015: 52016: 12017: 12018: 42019: 12022: 42024: 32025: 2
2007high 6 (2010) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LKF

136in 2024

2007: 141 days median2010: 178 days median2011: 187 days median2013: 266 days median2014: 169 days median2015: 140 days median2018: 267 days median2022: 79 days median2024: 136 days median
2007high 267 (2018) · low 79 (2022)2026

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

Recalls per year · LKF

3in 2022

2008: 22012: 22022: 3
2007high 3 (2022) · low 0 (2007)2026

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

Adverse event reports per year · LKF

95in 2025

2007: 362008: 592009: 532010: 462011: 982012: 1042013: 532014: 452015: 532016: 622017: 642018: 232019: 762020: 1192021: 1892022: 1002023: 882024: 1252025: 95
2007high 189 (2021) · low 23 (2018)2025

MAUDE reports naming product code LKF, 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
20073141036
20080—259
20092—053
20106178046
20113187098
20120—2104
20133266053
20143169045
20155140053
20161—062
20171—064
20184267023
20191—076
20200—0119
20210—0189
20224793100
20230—088
202431360125
20252—095
20260—0—

What is it indicated for?

The Modified Hysterosalpingography Set is to be used for the injection of contrast material in the examination of the uterus and fallopian tubes.

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

Also cleared against K953034

1 other device cites the same predicate.

  • K020951H/S Catheter Set (5F), Model 61-5005; H/S Catheter Set (7F), Model 61-5007Ackrad Laboratories · 20021 recall

More from Ackrad Laboratories

42 FDA decisions under this applicant name. See the company

  • K021272Sib Catheter, Model 61-7005Ackrad Laboratories · 2002
  • K020954H/S Procedure Tray (5F), H/S Procedure Tray (7F), H/S Elliptosphere Procedure Tray & Multipurpose Procedure…Ackrad Laboratories · 2002
  • K020951H/S Catheter Set (5F), Model 61-5005; H/S Catheter Set (7F), Model 61-5007Ackrad Laboratories · 20021 recall
  • K970492Intrauterine Insemination and Sonohysterography CatheterAckrad Laboratories · 19971 recall
  • K952542Ackrad Esophageal Balloon Catheter SetAckrad Laboratories · 1996

Recent decisions in LKF

The LKF category page

  • K253403FemVue® Controlled Saline-Air Device (FSA-300)Femasys, Inc. · 2025
  • K252260RELIEEV HSG Catheter (HSG7FA1)Li Medical Corporation, Ltd. · 2025
  • K242002FemVue MINI Saline-Air DeviceFemasys, Inc. · 2024
  • K240364RELIEEV Uterine Manipulator Injector (CUMI 5.0)Li Medical Corporation, Ltd. · 2024
  • K241693FemChec Controlled Saline-Air Device (FCD-250)Femasys, Inc. · 2024

https://510kreport.com/device/K961752 · printed Nov 6, 2026

Cite this page

510(k) Report. “K961752: H/S Catheter Set (61-3005, 61-3007, 61-3605, 61-3607).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961752

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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