510(k) Report

510(k) · Cleared

Cleared

H/S Procedure Tray (5F), H/S Procedure Tray (7F), H/S Elliptosphere Procedure Tray & Multipurpose Procedure Tray

K020954510(k) SpecialCleared Apr 24, 200230-day reviewClass II21 CFR 884.4530

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 Apr 24, 2002 as substantially equivalent to K881680 (Ackrad Laboratories, 1988) after a 30-day review. Its family tree reaches back 1 generation to 1988. 7 later devices descend from it.

Decided
Apr 24, 2002
Review
30 days
Class
Class II
Product code
LKF
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K881680 (1988). 7 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2011: 2 descendants cleared2015: 2 descendants cleared2024: 2 descendants cleared2025: 1 descendant clearedK881680 · Ackrad H/S Procedure Tray · Ackrad Laboratories · 19881990200020102020
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 4 descendants3 generations forward: 1 descendant K881680 · Ackrad H/S Procedure Tray · Ackrad Laboratories · 19880
  1. Root · 1 generation backK881680 Ackrad H/S Procedure TrayAckrad Laboratories · 1988
  2. This deviceK020954 H/S Procedure Tray (5F), H/S Procedure Tray (7F), H/S Elliptosphere…Ackrad Laboratories · 2002
  3. Descendant · cites it directly · 5 of its ownK110288 Femvue Saline-Air DeviceFemasys, Inc. · 2011
  4. Descendant · 2 generations on · 1 of its ownK241693 FemChec Controlled Saline-Air Device (FCD-250)Femasys, Inc. · 2024
  5. Descendant · 3 generations on · 0 of its ownK253403 FemVue® Controlled Saline-Air Device (FSA-300)Femasys, Inc. · 2025
  6. Descendant · 2 generations on · 0 of its ownK242002 FemVue MINI Saline-Air DeviceFemasys, Inc. · 2024
  7. Descendant · 2 generations on · 0 of its ownK142545 SonoFlow Sonohysterography and Sonohysterosalpingography DeviceCrossbay Medical, Inc. · 2015

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2011: 22015: 22024: 22025: 1
2011high 2 (2011) · low 0 (2012)2026

Most influential descendants

Showing 5 of 7 · See all
  • K110288Femvue Saline-Air DeviceFemasys, Inc. · 2011 · cites it directly5descendants
  • K241693FemChec Controlled Saline-Air Device (FCD-250)Femasys, Inc. · 2024 · 2 generations on1descendant
  • K253403FemVue® Controlled Saline-Air Device (FSA-300)Femasys, Inc. · 2025 · 3 generations on0descendants
  • K242002FemVue MINI Saline-Air DeviceFemasys, Inc. · 2024 · 2 generations on0descendants
  • K142545SonoFlow Sonohysterography and Sonohysterosalpingography DeviceCrossbay Medical, Inc. · 2015 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K881680Ackrad H/S Procedure TrayAckrad Laboratories1988—
0 (this device)K020954H/S Procedure Tray (5F), H/S Procedure Tray (7F), H/S Elliptosphere Procedure…Ackrad Laboratories2002—
+1K110288Femvue Saline-Air DeviceFemasys, Inc.2011—
+2K241693FemChec Controlled Saline-Air Device (FCD-250)Femasys, Inc.2024—
+3K253403FemVue® Controlled Saline-Air Device (FSA-300)Femasys, Inc.2025—
+2K242002FemVue MINI Saline-Air DeviceFemasys, Inc.2024—
+2K142545SonoFlow Sonohysterography and Sonohysterosalpingography DeviceCrossbay Medical, Inc.2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201120
201520
202420
202510
FIG. 1 — Lineage of K020954, 1988–2025Source: 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
*K881680Ackrad H/S Procedure Tray
Summary page 1
…ipurpose Procedure Tray Common Name: Hysterosalpingography or Hysterosonography Trays (Product Code LKF) Classification Name: Unclassified Ackrad H/S Procedure Tray K&881680, 7/15/88 April 23, 2002 Richard Hettenbach Vice President, Regulatory Affairs and Quality Assurance Ackrad Laboratories, Inc.…
Ackrad Laboratories1988—

What descends from it? (7)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K110288Femvue Saline-Air DeviceFemasys, Inc.20115
K110993Femchec Pressure Managemet DeviceFemasys, Inc.20110

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?

  • Its one ancestor has no recall.
  • Of its descendants, K110288 (Femasys, Inc., 2011) has gone furthest, with 5 descendants of its own.

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?

Procedure trays containing components intended for the delivery of diagnostic contrast media agents in the female reproductive tract for examination of the uterus and fallopian tubes (i.e. Hysterosalpingography or Hysterosonography).

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

More from Ackrad Laboratories

42 FDA decisions under this applicant name. See the company

  • K021272Sib Catheter, Model 61-7005Ackrad 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
  • K961752H/S Catheter Set (61-3005, 61-3007, 61-3605, 61-3607)Ackrad Laboratories · 19962 recalls
  • 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/K020954 · printed Nov 4, 2026

Cite this page

510(k) Report. “K020954: H/S Procedure Tray (5F), H/S Procedure Tray (7F), H/S Elliptosphere Procedure Tray & Multipurpose Procedure Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K020954

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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