510(k) Report

510(k) · Cleared

Recalled · Class II · 2025

Safe-T-Fill Capillary Blood Collection System

K981973510(k) TraditionalCleared Sep 3, 199890-day reviewClass II21 CFR 862.1675Recalls 1

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

Ram Scientific · JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

Cleared on Sep 3, 1998 as substantially equivalent to K896206 (Statspin Technologies, 1989) and 2 other predicates after a 90-day review. Its family tree reaches back 1 generation to 1983. It has been recalled once.

Decided
Sep 3, 1998
Review
90 days
Class
Class II
Product code
JKA
Recalls
1
Predicates
3

Its longest line of descent runs back 1 generation to K833475 (1983). 3 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1993: 1 other ancestor1989: 1 other ancestorK833475 · Capiject Sys Capillary Blood Collect · Terumo Medical Corp. · 198319801985199019952000
Other ancestors, by generation 1 generation back: 2 other ancestors K833475 · Capiject Sys Capillary Blood Collect · Terumo Medical Corp. · 19830
  1. Root · 1 generation backK833475 Capiject Sys Capillary Blood CollectTerumo Medical Corp. · 1983
  2. This deviceK981973 Safe-T-Fill Capillary Blood Collection SystemRam Scientific · 1998
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K833475Capiject Sys Capillary Blood CollectTerumo Medical Corp.1983—
0 (this device)K981973Safe-T-Fill Capillary Blood Collection SystemRam Scientific1998—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
199310
FIG. 1 — Lineage of K981973, 1983–1998Source: 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 JKA? 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 JKA device

  1. #1 K200027 Blood Collection Needle with/without Holder…score 15.6 · 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? (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
*K896206Statspin Statsampler
Summary page 1
…Phone (781) 433-0766 Fax (781) 433-0767 SAFE-T-FILL® Capillary Blood Collection System Capillary blood collection system Blood Specimen Collection Device StatSampler® (K896206); CapiJect® Capillary Blood Collection System (K833475); and Microtainer® Tube with EDTA and Microgard™ Closure (K931368). The S…
Statspin Technologies19891
*K833475Capiject Sys Capillary Blood Collect
Summary page 1
…apillary Blood Collection System Capillary blood collection system Blood Specimen Collection Device StatSampler® (K896206); CapiJect® Capillary Blood Collection System (K833475); and Microtainer® Tube with EDTA and Microgard™ Closure (K931368). The SAFE-T-FILL® Capillary Blood Collection System 1s a coll…
Terumo Medical Corp.1983—
*K931368Microtainer Brand Tube with Edta
Summary page 1
…Blood Specimen Collection Device StatSampler® (K896206); CapiJect® Capillary Blood Collection System (K833475); and Microtainer® Tube with EDTA and Microgard™ Closure (K931368). The SAFE-T-FILL® Capillary Blood Collection System 1s a collection device used to draw capillary blood from the finger or heel…
Bd Becton Dickinson Vacutainer Systems Preanalytic19932

Also cleared against K896206: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
May 5, 2025Class IIZ-0372-2026Component design/selectionAll RAM SAFE-T-FILL Micro Capillary Blood Collection tubes manufactured between July 31, 2023 to February 28, 2025 cause false positive results when used with Magellan Diagnostics LeadCare Testing Systems. False positive lead results may…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • 2 of the 3 ancestors have a recall of any class.
  • 1 other device also cites its predicate K896206.

How does its category compare?

All JKA devices

JKA Tubes, Vials, Systems, Serum Separators, Blood Collection: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JKA

7in 2025

2007: 42008: 22009: 22010: 42012: 12013: 32014: 12015: 12016: 42017: 22018: 12019: 62020: 62021: 42022: 92023: 172024: 62025: 72026 (partial year): 8
2007high 17 (2023) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JKA

115in 2025

2007: 281 days median2010: 28 days median2013: 244 days median2016: 116 days median2019: 181 days median2020: 181 days median2021: 217 days median2022: 164 days median2023: 189 days median2024: 240 days median2025: 115 days median2026 (partial year): 250 days median
2007high 281 (2007) · low 28 (2010)2026

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

Recalls per year · JKA

13in 2025

2007: 32008: 32009: 32010: 42011: 142012: 22013: 12014: 12015: 62016: 12017: 22018: 22019: 92021: 32022: 22023: 22025: 132026 (partial year): 1
2007high 14 (2011) · low 0 (2020)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JKA

6,089in 2025

2007: 732008: 782009: 422010: 372011: 672012: 542013: 332014: 682015: 412016: 652017: 2,0392018: 9,7312019: 6,4692020: 3,7742021: 3,6102022: 3,3752023: 4,4002024: 4,6092025: 6,089
2007high 9,731 (2018) · low 33 (2013)2025

MAUDE reports naming product code JKA, 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
20074281373
20082—378
20092—342
2010428437
20110—1467
20121—254
20133244133
20141—168
20151—641
20164116165
20172—22,039
20181—29,731
2019618196,469
2020618103,774
2021421733,610
2022916423,375
20231718924,400
2024624004,609
20257115136,089
202682501—

What is it indicated for?

The SAFE-T-FILL® Capillary Blood Collection System is indicated for the drawing of blood via capillary action from a finger or heelstick to be placed in a microtube for the purposes of obtaining a blood sample for diagnostic hematology testing.

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

Also cleared against K896206

1 other device cites the same predicate.

  • K983517Safe-T-Fill Capillary Blood Collection SystemRam Scientific · 199811 recalls

More from Ram Scientific

2 FDA decisions under this applicant name. See the company

  • K983517Safe-T-Fill Capillary Blood Collection SystemRam Scientific · 199811 recalls

Recent decisions in JKA

The JKA category page

  • K260857Sol-Guard™ Safety Pull Button Collection Set; Sol-Guard™ XtraThin Safety Pull-Button Blood Collection SetSol-Millennium Medical, Inc. · 2026
  • K252344BD Vacutainer® Serum Blood Collection Tubes; BD Vacutainer® Rapid Serum Tubes (RST)Becton, Dickinson and Company · 2026
  • K262215Profoject™ Safety Sliding Blood Collection SetCMT Health PTE., Ltd. · 2026
  • K252899Female Culture Device; Male Culture Device; Transfer Device; Access DeviceZhejiang Kindly Medical Device Co., Ltd. · 2026
  • K260128BD Preset™ and BD A-Line™ Arterial Blood Collection SyringesBecton, Dickinson and Company · 2026

https://510kreport.com/device/K981973 · printed Nov 4, 2026

Cite this page

510(k) Report. “K981973: Safe-T-Fill Capillary Blood Collection System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981973

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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