510(k) Report

510(k) · Cleared

Cleared

Imbibe Bone Marrow Aspiration Needle

K050795510(k) TraditionalCleared Jun 3, 200566-day reviewClass II21 CFR 876.1075

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

Orthovita, Inc. · KNW Instrument, Biopsy

Cleared on Jun 3, 2005 as substantially equivalent to K940025 (Manan Medical Products, Inc., 1994) and 2 other predicates after a 66-day review. Its family tree reaches back 2 generations to 2002. 19 later devices descend from it.

Decided
Jun 3, 2005
Review
66 days
Class
Class II
Product code
KNW
Recalls
None
Predicates
3

Its longest line of descent runs back 2 generations to K023088 (2002). 5 ancestors in all, the oldest K940025 (1994). 19 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor1994: 1 other ancestor2003: 1 other ancestor2013: 1 descendant cleared2015: 3 descendants cleared2014: 3 descendants cleared2005: 1 descendant cleared2019: 2 descendants cleared2018: 1 descendant cleared2024: 1 descendant cleared2025: 1 descendant cleared2021: 3 descendants cleared2026: 1 descendant cleared2023: 1 descendant cleared2020: 1 descendant clearedK023088 · Bone Graft Syringe, Model 8600-00X0 · Wrightmedicaltechnologyinc · 2002K041991 · Aspirex - Bone Marrow Aspirate Kit · Isotis Orthobiologics, Inc. · 20041990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 1 other ancestor 1 generation forward: 5 descendants2 generations forward: 11 descendants3 generations forward: 3 descendants K041991 · Aspirex - Bone Marrow Aspirate Kit · Isotis Orthobiologics, Inc. · 2004K023088 · Bone Graft Syringe, Model 8600-00X0 · Wrightmedicaltechnologyinc · 20020
  1. Root · 2 generations backK023088 Bone Graft Syringe, Model 8600-00X0Wrightmedicaltechnologyinc · 2002
  2. 1 generation backK041991 Aspirex - Bone Marrow Aspirate KitIsotis Orthobiologics, Inc. · 2004
  3. This deviceK050795 Imbibe Bone Marrow Aspiration NeedleOrthovita, Inc. · 2005
  4. Descendant · cites it directly · 12 of its ownK131157 Ranfac Bone Marrow Aspiration NeedleRanfac, Corp. · 2013
  5. Descendant · 2 generations on · 5 of its ownK140991 Ranfac Aspiration Needle with Adjustable GuideRanfac, Corp. · 2014
  6. Descendant · 2 generations on · 4 of its ownK150563 Marrow Cellution Bone Marrow Aspiration NeedleRanfac, Corp. · 2015
  7. Descendant · 2 generations on · 1 of its ownK240664 ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC · 2024
  8. Descendant · 3 generations on · 1 of its ownK223612 Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA)Ranfac Corporation · 2023

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2005: 12013: 12014: 32015: 32018: 12019: 22020: 12021: 32023: 12024: 12025: 12026: 1
2005high 3 (2014) · low 0 (2006)2026

Most influential descendants

Showing 5 of 19 · See all
  • K131157Ranfac Bone Marrow Aspiration NeedleRanfac, Corp. · 2013 · cites it directly12descendants
  • K140991Ranfac Aspiration Needle with Adjustable GuideRanfac, Corp. · 2014 · 2 generations on5descendants
  • K150563Marrow Cellution Bone Marrow Aspiration NeedleRanfac, Corp. · 2015 · 2 generations on4descendants
  • K240664ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC · 2024 · 2 generations on1descendant
  • K223612Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA)Ranfac Corporation · 2023 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K023088Bone Graft Syringe, Model 8600-00X0Wrightmedicaltechnologyinc2002—
−1K041991Aspirex - Bone Marrow Aspirate KitIsotis Orthobiologics, Inc.2004—
0 (this device)K050795Imbibe Bone Marrow Aspiration NeedleOrthovita, Inc.2005—
+1K131157Ranfac Bone Marrow Aspiration NeedleRanfac, Corp.2013—
+2K140991Ranfac Aspiration Needle with Adjustable GuideRanfac, Corp.2014—
+2K150563Marrow Cellution Bone Marrow Aspiration NeedleRanfac, Corp.2015—
+2K240664ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC2024—
+3K223612Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA)Ranfac Corporation2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
200010
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
201310
201430
201530
201810
201920
202010
202130
202310
202410
202510
202610
FIG. 1 — Lineage of K050795, 2002–2026Source: 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 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 KNW? 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 KNW device

  1. #1 K260572 Marrow Marxmanscore 14.5 · 10 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? (3)

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
*K940025Manan Bone Marrow Harvest Needles
Summary page 1
…ation and Injection, Disposable (Product Code GAA) Predicate Devices 510(K) Number Predicate Description Manufactured By K(940025 Bone Marrow Harvest Needle Manan Medical K00 1132 Bone Biopsy Needle…
Manan Medical Products, Inc.1994—
*K001132Bone Biopsy Needle
Summary page 1
…Predicate Description Manufactured By K(940025 Bone Marrow Harvest Needle Manan Medical K00 1132 Bone Biopsy Needle Promex K041991 Aspirex - Bone Marrow Aspirat…
Promex, Inc.2000—
*K041991Aspirex - Bone Marrow Aspirate Kit
Summary page 1
…K(940025 Bone Marrow Harvest Needle Manan Medical K00 1132 Bone Biopsy Needle Promex K041991 Aspirex - Bone Marrow Aspiration Kit Isotis Orthobiologics Intended Use / Indications for Use…
Isotis Orthobiologics, Inc.2004—

Also cleared against K940025: 1 other device →

What descends from it? (19)

See all 19

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

NumberDeviceApplicantDecidedDescendants
K131157Ranfac Bone Marrow Aspiration NeedleRanfac, Corp.201312
K140868Stryker Kwic NeedleOrthovita, Inc.20141
K140414Imbibe NeedleOrthovita, Inc.20141
K143546Imbibe Aspirating XIA TapsStryker Corporation20150
K052435Pneumrx Family of Biopsy Needles and KitsPneumrx, Inc.20050

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?

  • The line of descent spans 3 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
  • None of the 5 ancestors has a recall.
  • Of its descendants, K131157 (Ranfac, Corp., 2013) has gone furthest, with 12 descendants of its own.
  • 1 other device also cites its predicate K940025.

How does its category compare?

All KNW devices

KNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KNW

12in 2025

2007: 62008: 42009: 62010: 32011: 102012: 72013: 32014: 82015: 102016: 92017: 82018: 72019: 52020: 82021: 92022: 82023: 72024: 52025: 122026 (partial year): 7
2007high 12 (2025) · low 3 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KNW

178in 2025

2007: 94 days median2008: 53 days median2009: 35 days median2010: 57 days median2011: 64 days median2012: 94 days median2013: 100 days median2014: 95 days median2015: 106 days median2016: 127 days median2017: 90 days median2018: 71 days median2019: 94 days median2020: 92 days median2021: 54 days median2022: 203 days median2023: 164 days median2024: 114 days median2025: 178 days median2026 (partial year): 29 days median
2007high 203 (2022) · low 35 (2009)2026

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

Recalls per year · KNW

1in 2024

2007: 12008: 72009: 32010: 22011: 52012: 12013: 1, 1 Class I2014: 32016: 52017: 12019: 42021: 32022: 32023: 22024: 12026 (partial year): 4, 3 Class I
2007high 7 (2008) · low 0 (2015)2026

Class I (4 since 2007) Class II/III not classified

Adverse event reports per year · KNW

1,667in 2025

2007: 7662008: 3632009: 3512010: 1622011: 672012: 932013: 982014: 1932015: 5912016: 2972017: 7602018: 1,0122019: 4,1952020: 5,1202021: 1,0202022: 5352023: 9312024: 1,2832025: 1,667
2007high 5,120 (2020) · low 67 (2011)2025

MAUDE reports naming product code KNW, 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
20076941766
20084537363
20096353351
20103572162
20111064567
2012794193
201331001 (1)98
20148953193
2015101060591
201691275297
20178901760
201877101,012
201959444,195
202089205,120
202195431,020
202282033535
202371642931
2024511411,283
20251217801,667
20267294 (3)—

What is it indicated for?

The Imbibe Bone Marrow Aspiration Needle is for use in aspirating Bone Marrow or Autologous blood by use of a syringe. The bone marrow or autologous blood may be combined with bone graft or bone void filler.

Indications for use as stated in the FDA summary.

Also cleared against K940025

1 other device cites the same predicate.

  • K961959MD Tech Biopsy Set for Bone and Bone MarrowMedical Device Technologies, Inc. · 1996

More from Orthovita, Inc.

23 FDA decisions under this applicant name. See the company

  • K163621Vitoss Bioactive (BA) InjectableOrthovita, Inc. · 2017
  • K161447HydroSet XTOrthovita, Inc. · 20162 recalls
  • K153608Vitoss BiModal Bone Graft Substitute Foam StripOrthovita, Inc. · 2016
  • K153306Imbibe NeedleOrthovita, Inc. · 2015
  • K140868Stryker Kwic NeedleOrthovita, Inc. · 2014

Recent decisions in KNW

The KNW category page

  • K260517Automatic Core Biopsy InstrumentZhejiang Curaway Medical Technology Co., Ltd. · 2026
  • K262571EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemBard Peripheral Vascular, Inc. · 2026
  • K262792Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)Hologic, Inc. · 2026
  • K260572Marrow MarxmanMedimetrix, LLC · 2026
  • K261196Promisemed VeriEcto Automatic Biopsy NeedlesPromisemed Hangzhou Meditech Co., Ltd. · 2026

https://510kreport.com/device/K050795 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050795: Imbibe Bone Marrow Aspiration Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050795

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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