510(k) Report

510(k) · Cleared

Cleared

Tissu-Trans

K050797510(k) TraditionalCleared Jul 13, 2005106-day reviewClass I21 CFR 880.6960

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

Shippert Medical Technologies Corp. · KYZ Syringe, Irrigating (Non Dental)

Cleared on Jul 13, 2005 as substantially equivalent to K884749 (Johnson & Johnson Patient Care, Inc., 1988) after a 106-day review. Its family tree reaches back 1 generation to 1988. 36 later devices descend from it.

Decided
Jul 13, 2005
Review
106 days
Class
Class I
Product code
KYZ
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K884749 (1988). 36 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2009: 2 descendants cleared2007: 1 descendant cleared2013: 2 descendants cleared2010: 4 descendants cleared2008: 1 descendant cleared2019: 3 descendants cleared2012: 5 descendants cleared2017: 5 descendants cleared2014: 4 descendants cleared2015: 2 descendants cleared2020: 2 descendants cleared2018: 1 descendant cleared2021: 2 descendants cleared2016: 1 descendant cleared2022: 1 descendant clearedK884749 · Johnson & Johnson Sterile Spray Tip Syringe · Johnson & Johnson Patient Care, Inc. · 19881990200020102020
Descendants, by generation 1 generation forward: 6 descendants2 generations forward: 11 descendants3 generations forward: 12 descendants4 generations forward: 2 descendants5 generations forward: 3 descendants6 generations forward: 1 descendant7 generations forward: 1 descendant K884749 · Johnson & Johnson Sterile Spray Tip Syringe · Johnson & Johnson Patient Care, Inc. · 19880+5
  1. Root · 1 generation backK884749 Johnson & Johnson Sterile Spray Tip SyringeJohnson & Johnson Patient Care, Inc. · 1988
  2. This deviceK050797 Tissu-TransShippert Medical Technologies Corp. · 2005
  3. Descendant · cites it directly · 34 of its ownK072587 Cytori Aft SystemCytori Therapeutics, Inc. · 2007
  4. Descendant · cites it directly · 17 of its ownK092482 Tissu Trans Filtron, Models 3-TT-Filtron 2000-500Shippert Medical Technologies Corp. · 2009 · Recalled
  5. Descendant · cites it directly · 12 of its ownK081848 Lipose Fat Transfer SystemLipose Corp. · 2008
  6. Descendant · 2 generations on · 11 of its ownK120902 GID 700The Gid Group, Inc. · 2012 · Recalled
  7. Descendant · 2 generations on · 8 of its ownK100114 Fat Concentration SystemBiomet, Inc. · 2010

Showing 5 of 36 descendants. See all descendants

Descendants cleared per year

2007: 12008: 12009: 22010: 42012: 52013: 22014: 42015: 22016: 12017: 52018: 12019: 32020: 22021: 22022: 1
2007high 5 (2012) · low 0 (2011)2026

Most influential descendants

Showing 5 of 36 · See all
  • K072587Cytori Aft SystemCytori Therapeutics, Inc. · 2007 · cites it directly34descendants
  • K092482Tissu Trans Filtron, Models 3-TT-Filtron 2000-500Shippert Medical Technologies Corp. · 2009 · cites it directly17descendants
  • K081848Lipose Fat Transfer SystemLipose Corp. · 2008 · cites it directly12descendants
  • K120902GID 700The Gid Group, Inc. · 2012 · 2 generations on11descendants
  • K100114Fat Concentration SystemBiomet, Inc. · 2010 · 2 generations on8descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K884749Johnson & Johnson Sterile Spray Tip SyringeJohnson & Johnson Patient Care, Inc.1988—
0 (this device)K050797Tissu-TransShippert Medical Technologies Corp.2005—
+1K072587Cytori Aft SystemCytori Therapeutics, Inc.2007—
+1K092482Tissu Trans Filtron, Models 3-TT-Filtron 2000-500Shippert Medical Technologies Corp.20098
+1K081848Lipose Fat Transfer SystemLipose Corp.2008—
+2K120902GID 700The Gid Group, Inc.20121
+2K100114Fat Concentration SystemBiomet, Inc.2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200810
200920
201040
201250
201320
201440
201520
201610
201750
201810
201930
202020
202120
202210
FIG. 1 — Lineage of K050797, 1988–2022Source: 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 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KYZ? 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? (2)

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
*K884749Johnson & Johnson Sterile Spray Tip Syringe
Summary page 2
…valent to the predicate devices, and is safe and effective. The device design and materials used, are similar to those of the Predicate Device Johnson & Johnson Syringe k884749 and LipiVage, k# unknown, and also to most of the piston syringes in the Product Code KYZ. As stated in CFR 880.6960, (product c…
Johnson & Johnson Patient Care, Inc.1988—
*—LipiVage
Named without a submission number
—

What descends from it? (36)

See all 36

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

NumberDeviceApplicantDecidedDescendants
K072587Cytori Aft SystemCytori Therapeutics, Inc.200734
K092482Tissu Trans Filtron, Models 3-TT-Filtron 2000-500Shippert Medical Technologies Corp.200917
K081848Lipose Fat Transfer SystemLipose Corp.200812
K083455Lipokit with Disposable 50CC Aft Syringe, Model ZLK-100Medi-Khan USA, Inc.20095
K092923Cytori Puregraft 250/Pure SystemCytori Therapeutics, Inc.20102
K131963Tautona Injector DeviceTautona Group, LLC20130

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, K072587 (Cytori Therapeutics, Inc., 2007) has gone furthest, with 34 descendants of its own.

How does its category compare?

All KYZ devices

KYZ Syringe, Irrigating (Non Dental): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KYZ

1in 2020

2009: 12011: 12020: 1
2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KYZ

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

Recalls per year · KYZ

1in 2023

2009: 12010: 22011: 12016: 52018: 12023: 1, 1 Class I2026 (partial year): 1
2007high 5 (2016) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · KYZ

28in 2025

2008: 42009: 32010: 22011: 42012: 12013: 122014: 102015: 112016: 82017: 522018: 762019: 692020: 882021: 412022: 112023: 142024: 1062025: 28
2007high 106 (2024) · low 0 (2007)2025

MAUDE reports naming product code KYZ, 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—00
20080—04
20091—13
20100—22
20111—14
20120—01
20130—012
20140—010
20150—011
20160—58
20170—052
20180—176
20190—069
20201—088
20210—041
20220—011
20230—1 (1)14
20240—0106
20250—028
20260—1—

What is it indicated for?

Tissu-TransTM is a piston syringe used in the aspiration harvesting, filtering and transferring of autologous tissue.

Indications for use as stated in the FDA 510(k) statement.

More from Shippert Medical Technologies Corp.

13 FDA decisions under this applicant name. See the company

  • K102117Tissu Trans Filtron Syringe FillShippert Medical Technologies Corp. · 2010
  • K092482Tissu Trans Filtron, Models 3-TT-Filtron 2000-500Shippert Medical Technologies Corp. · 20098 recalls
  • K092022Tissu Trans Harvest TubingShippert Medical Technologies Corp. · 2009
  • K964855Expandacell Eye Spear, Eye Wick, Wick Drain and Corneal ShieldShippert Medical Technologies Corp. · 1997
  • K964334Expandacell Anti-Fog Instrument Wipe (with Alcohol)/(Without)Shippert Medical Technologies Corp. · 1996

Recent decisions in KYZ

The KYZ category page

  • K201877OtoSet- Ear Cleaning SystemSafkan, Inc. · 2020
  • K102563Single Cannula Extended ApplicatorMicromedics, Inc. · 2011
  • K092022Tissu Trans Harvest TubingShippert Medical Technologies Corp. · 2009
  • K991254QS Delivery SystemSub-Q, Inc. · 1999
  • K982435Irrigation Syringe KitSub-Q, Inc. · 1998

https://510kreport.com/device/K050797 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050797: Tissu-Trans.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050797

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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