510(k) Report

510(k) · Cleared

Cleared

Biosurgical, Corp. Multi Chamber Suction Syringe

K964597510(k) TraditionalCleared Sep 8, 1997294-day reviewClass II21 CFR 880.5860

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

Biosurgical Corp. · FMF Syringe, Piston

Cleared on Sep 8, 1997 after a 294-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 8 later devices descend from it.

Decided
Sep 8, 1997
Review
294 days
Class
Class II
Product code
FMF
Recalls
None
Predicates
0

8 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2000: 1 descendant cleared1999: 1 descendant cleared2002: 2 descendants cleared2004: 1 descendant cleared2005: 1 descendant cleared2007: 2 descendants cleared1995200020052010201520202025
  1. This deviceK964597 Biosurgical, Corp. Multi Chamber Suction SyringeBiosurgical Corp. · 1997
  2. Descendant · cites it directly · 3 of its ownK994023 Haemacure Hemamyst Surgical Applicator System H-AS01Haemacure Corp. · 2000
  3. Descendant · cites it directly · 3 of its ownK992351 Sealouette Fibrin Sealant ApplicatorBiosurgical Corp. · 1999
  4. Descendant · 2 generations on · 1 of its ownK050998 Confluent Surgical Micromyst Applicator and Air Pump, Models…Confluent Surgical,Inc · 2005
  5. Descendant · 2 generations on · 1 of its ownK020666 Duploject Easy-Prep System 1ML, 2ML, 5MLBaxter Healthcare Corp · 2002 · Recalled
  6. Descendant · 2 generations on · 1 of its ownK014088 DuploreachBaxter Healthcare Corp · 2002

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

1999: 12000: 12002: 22004: 12005: 12007: 2
1999high 2 (2002) · low 0 (2001)2026

Most influential descendants

Showing 5 of 8 · See all
  • K994023Haemacure Hemamyst Surgical Applicator System H-AS01Haemacure Corp. · 2000 · cites it directly3descendants
  • K992351Sealouette Fibrin Sealant ApplicatorBiosurgical Corp. · 1999 · cites it directly3descendants
  • K050998Confluent Surgical Micromyst Applicator and Air Pump, Models 20-5000, AP-a-6063Confluent Surgical,Inc · 2005 · 2 generations on1descendant
  • K020666Duploject Easy-Prep System 1ML, 2ML, 5MLBaxter Healthcare Corp · 2002 · 2 generations on1descendant
  • K014088DuploreachBaxter Healthcare Corp · 2002 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K964597Biosurgical, Corp. Multi Chamber Suction SyringeBiosurgical Corp.1997—
+1K994023Haemacure Hemamyst Surgical Applicator System H-AS01Haemacure Corp.2000—
+1K992351Sealouette Fibrin Sealant ApplicatorBiosurgical Corp.1999—
+2K050998Confluent Surgical Micromyst Applicator and Air Pump, Models 20-5000, AP-a-6063Confluent Surgical,Inc2005—
+2K020666Duploject Easy-Prep System 1ML, 2ML, 5MLBaxter Healthcare Corp20021
+2K014088DuploreachBaxter Healthcare Corp2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200010
200220
200410
200510
200720
FIG. 1 — Lineage of K964597, 1997–2007Source: 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 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 FMF? 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 FMF device

  1. #1 K241821 Luer Lock Syringe with Safety Needle; Luer…score 16.2 · 8 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’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K994023Haemacure Hemamyst Surgical Applicator System H-AS01Haemacure Corp.20003
K992351Sealouette Fibrin Sealant ApplicatorBiosurgical Corp.19993

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, K994023 (Haemacure Corp., 2000) has gone furthest, with 3 descendants of its own.

How does its category compare?

All FMF devices

FMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FMF

13in 2025

2007: 232008: 92009: 142010: 112011: 162012: 92013: 122014: 132015: 112016: 122017: 132018: 82019: 112020: 152021: 202022: 242023: 222024: 142025: 132026 (partial year): 9
2007high 24 (2022) · low 8 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FMF

114in 2025

2007: 90 days median2008: 74 days median2009: 94 days median2010: 130 days median2011: 109 days median2012: 86 days median2013: 154 days median2014: 84 days median2015: 87 days median2016: 146 days median2017: 135 days median2018: 87 days median2019: 146 days median2020: 107 days median2021: 175 days median2022: 211 days median2023: 173 days median2024: 130 days median2025: 114 days median2026 (partial year): 239 days median
2007high 239 (2026) · low 74 (2008)2026

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

Recalls per year · FMF

19in 2023

2007: 62008: 112009: 152010: 122011: 32012: 62013: 12014: 12015: 22017: 32018: 22019: 12020: 22021: 12022: 22023: 19, 18 Class I2026 (partial year): 2, 1 Class I
2007high 19 (2023) · low 0 (2016)2026

Class I (19 since 2007) Class II/III not classified

Adverse event reports per year · FMF

4,181in 2025

2007: 6742008: 6912009: 9132010: 6792011: 1862012: 3072013: 3262014: 2442015: 2732016: 6842017: 1,8582018: 3,9522019: 5,8632020: 5,3342021: 5,8742022: 5,2332023: 5,2142024: 5,1222025: 4,181
2007high 5,874 (2021) · low 186 (2011)2025

MAUDE reports naming product code FMF, 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
200723906674
200897411691
2009149415913
20101113012679
2011161093186
20129866307
2013121541326
201413841244
201511872273
2016121460684
20171313531,858
201888723,952
20191114615,863
20201510725,334
20212017515,874
20222421125,233
20232217319 (18)5,214
20241413005,122
20251311404,181
202692392 (1)—

What is it indicated for?

The BioSurgical Corp. Multi Chamber Suction Syringe is indicated for the mixing and application of FDA approved fluids to wounds, the delivery of antibiotics, and other wound treatment fluids. It can also be attached to standard hospital wall suction for removal of fluid debris, excess tissue or foreign particles in the wound.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

More from Biosurgical Corp.

4 FDA decisions under this applicant name. See the company

  • K000438Multi Lumen Suction Syringe Spray DispenserBiosurgical Corp. · 2000
  • K000048Sealouette Fibrin Sealant Extended Droplet Applicator, Model TE-1Biosurgical Corp. · 2000
  • K992351Sealouette Fibrin Sealant ApplicatorBiosurgical Corp. · 1999

Recent decisions in FMF

The FMF category page

  • K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLC · 2026
  • K252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc. · 2026
  • K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd. · 2026
  • K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLC · 2026
  • K253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc. · 2026

https://510kreport.com/device/K964597 · printed Nov 4, 2026

Cite this page

510(k) Report. “K964597: Biosurgical, Corp. Multi Chamber Suction Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964597

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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