510(k) Report

510(k) · Cleared

Cleared

Uterine Manipulator Injector Cannula, Sterile, Model R 57-450

K010056510(k) TraditionalCleared Feb 1, 200124-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

A & A Medical, Inc. · LKF Cannula, Manipulator/Injector, Uterine

Cleared on Feb 1, 2001 after a 24-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Feb 1, 2001
Review
24 days
Class
Class II
Product code
LKF
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared200020052010201520202025
  1. This deviceK010056 Uterine Manipulator Injector Cannula, Sterile, Model R 57-450A & A Medical, Inc. · 2001
  2. Descendant · cites it directly · 0 of its ownK051160 ManipusealInsitu Systems · 2005

Most influential descendants

Showing 1 of 1 · See all
  • K051160ManipusealInsitu Systems · 2005 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K010056Uterine Manipulator Injector Cannula, Sterile, Model R 57-450A & A Medical, Inc.2001—
+1K051160ManipusealInsitu Systems2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
FIG. 1 — Lineage of K010056, 2001–2005Source: 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K051160ManipusealInsitu Systems20050

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?

  • Of its descendants, K051160 (Insitu Systems, 2005) has gone furthest, with 0 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—

More from A & A Medical, Inc.

23 FDA decisions under this applicant name. See the company

  • K013491HSG Catheter Set, 5F Model RGS0947, HSG Catheter Set, 7F, Model R65-948A & A Medical, Inc. · 2001
  • K013437SF SH Catheter, Model R65-945A & A Medical, Inc. · 2001
  • K003949Tacker, Model R65-933A & A Medical, Inc. · 2001
  • K011512Mmodification to LaminariaA & A Medical, Inc. · 2001
  • K010510Balloon Cannula, Short, Model R65-985; Balloon Cannula, Long, Model R65-985-1A & A Medical, Inc. · 2001

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/K010056 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010056: Uterine Manipulator Injector Cannula, Sterile, Model R 57-450.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010056

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026