510(k) · Cleared

Cleared

Phaseal, System for Sealed Handling of Chemotherapeutic Agents

K972527510(k) TraditionalCleared Sep 18, 199773-day reviewClass II21 CFR 880.5440

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

Quality System Consulting · FPA Set, Administration, Intravascular

Cleared on Sep 18, 1997 as substantially equivalent to K883614 (Survival Technology, Inc., 1988) and 2 other predicates after a 73-day review. Its family tree reaches back 1 generation to 1988. 3 of the 60 devices in its family, counting itself, have a Class I recall. 56 later devices descend from it.

Decided: Sep 18, 1997
Review: 73 days
Class: Class II
Product code: FPA
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K883614 (1988). 3 ancestors in all. 56 later devices descend from it, 5 citing it directly. 3 of the 60 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK883614 Cytoguard (R)Survival Technology, Inc. · 1988
This deviceK972527 Phaseal, System for Sealed Handling of Chemotherapeutic AgentsQuality System Consulting · 1997
Descendant · cites it directly · 49 of its ownK980381 Phaseal, Closed System Forhandling of Parenteral Drugs, Additional…Carmel Pharma Ab. · 1998
Descendant · 2 generations on · 38 of its ownK023747 PhasealCarmel Pharma Ab. · 2002
Descendant · 3 generations on · 37 of its ownK110023 Infusion Adapter C100Carmel Pharma Ab. · 2011
Descendant · cites it directly · 36 of its ownK092782 Injector Luer, Model N34, Injector Luer Lock, Model N35, Injector…Carmel Pharma Ab. · 2009
Descendant · 2 generations on · 36 of its ownK060866 Phaseal - Closed System for the Preparation and Administration of…Carmel Pharma Ab. · 2006

Showing 5 of 56 descendants. See all descendants

Descendants cleared per year

1998high 8 (2024) · low 0 (1999)2026

Class I recalls in this family

K072759 VIAL2BAG2 generations on · 2007
K131549 Chemolock, Chemolock Port3 generations on · 2013
K170095 Vial2Bag Direct Connect4 generations on · 2017

Most influential descendants

Showing 5 of 56 · See all

K980381Phaseal, Closed System Forhandling of Parenteral Drugs, Additional Administration…Carmel Pharma Ab. · 1998 · cites it directly49descendants
K023747PhasealCarmel Pharma Ab. · 2002 · 2 generations on38descendants
K110023Infusion Adapter C100Carmel Pharma Ab. · 2011 · 3 generations on37descendants
K092782Injector Luer, Model N34, Injector Luer Lock, Model N35, Injector Luer Lock, N35C…Carmel Pharma Ab. · 2009 · cites it directly36descendants
K060866Phaseal - Closed System for the Preparation and Administration of Parenteral DrugsCarmel Pharma Ab. · 2006 · 2 generations on36descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K883614	Cytoguard (R)	Survival Technology, Inc.	1988	—
0 (this device)	K972527	Phaseal, System for Sealed Handling of Chemotherapeutic Agents	Quality System Consulting	1997	—
+1	K980381	Phaseal, Closed System Forhandling of Parenteral Drugs, Additional…	Carmel Pharma Ab.	1998	—
+2	K023747	Phaseal	Carmel Pharma Ab.	2002	—
+3	K110023	Infusion Adapter C100	Carmel Pharma Ab.	2011	—
+1	K092782	Injector Luer, Model N34, Injector Luer Lock, Model N35, Injector Luer Lock…	Carmel Pharma Ab.	2009	—
+2	K060866	Phaseal - Closed System for the Preparation and Administration of Parenteral…	Carmel Pharma Ab.	2006	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0
1995	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
2002	1	0
2005	1	0
2006	2	0
2007	3	1
2009	3	0
2010	1	0
2011	1	0
2012	2	0
2013	3	1
2014	4	0
2015	2	0
2017	4	1
2018	4	0
2020	3	0
2021	2	0
2022	1	0
2023	4	0
2024	8	0
2025	6	0

FIG. 1 — Lineage of K972527, 1988–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

3 devices in this family have a Class I recall. 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 FPA device

#1 K243841 Sparta Infusion Set for Insulinscore 13.4 · 3 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (4)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K883614	Cytoguard (R) Summary page 1 …r Connector Luer Lock Infusion Set Predicate Devices e Bristol-Myres Squibb/Mead Johnson Oncology Products (Survival Technology), CytoGuard® Drug Reconstitution Device, K883614 Becton Dickinson, SafetyGlide™ Shielding IM Injection Needle, K951254 Sherwod Davis & Geck, Monoject® Luer Adapter, K940961 Codan…	Survival Technology, Inc.	1988	—
*	K951254	Safetyglide Needle Summary page 1 …Squibb/Mead Johnson Oncology Products (Survival Technology), CytoGuard® Drug Reconstitution Device, K883614 Becton Dickinson, SafetyGlide™ Shielding IM Injection Needle, K951254 Sherwod Davis & Geck, Monoject® Luer Adapter, K940961 Codan Medlon, IV Administration Set ~ Catalog #443, preammendment device P…	Bd Becton Dickinson Vacutainer Systems Preanalytic	1995	4
*	K940961	Monoject Luer Adapter Summary page 1 …logy), CytoGuard® Drug Reconstitution Device, K883614 Becton Dickinson, SafetyGlide™ Shielding IM Injection Needle, K951254 Sherwod Davis & Geck, Monoject® Luer Adapter, K940961 Codan Medlon, IV Administration Set ~ Catalog #443, preammendment device Product Description, Function, Safety and Efficacy The…	Sherwood Medical Co.	1994	—
*	—	Codan Medlon, IV Administration Set — Catalog #443 Named without a submission number			—

What descends from it? (56)

See all 56

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

Number	Device	Applicant	Decided	Descendants
K980381	Phaseal, Closed System Forhandling of Parenteral Drugs, Additional Administration…	Carmel Pharma Ab.	1998	49
K092782	Injector Luer, Model N34, Injector Luer Lock, Model N35, Injector Luer Lock, N35C…	Carmel Pharma Ab.	2009	36
K120384	Protector, Injector, Connector	Bd Medical-Medical Surgical Systems	2012	35
K053049	Alaris Safety Male Luer	Cardinal Health, Alaris Products	2006	14
K083152	Equashield System	Plastmed, Ltd.	2009	9

Has anything in its family been recalled? (3 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K072759VIAL2BAGMedimop Medical Projects, Ltd. · 2007 · 2 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
K131549Chemolock, Chemolock PortIcu Medical, Inc. · 2013 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 12 Class I recalls
K170095Vial2Bag Direct ConnectMedimop Medical Project, Ltd. · 2017 · 4 generations on · ◆ in the 2017 descendants bar of FIG. 12 Class I recalls

What does this lineage say?

1 of the 3 ancestors has a recall of any class.
Of its descendants, K980381 (Carmel Pharma Ab., 1998) has gone furthest, with 49 descendants of its own.

How does its category compare?

All FPA devices

FPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FPA

11in 2025

2007high 23 (2010) · low 4 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FPA

225in 2025

2007high 340 (2023) · low 75 (2007)2026

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

Recalls per year · FPA

98in 2025

2007high 166 (2009) · low 1 (2021)2026

Class I (17 since 2007) Class II/III not classified

Adverse event reports per year · FPA

34,506in 2025

2007high 47,210 (2024) · low 1,499 (2007)2025

MAUDE reports naming product code FPA, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	16	75	17	1,499
2008	18	89	15	1,941
2009	10	166	166	2,512
2010	23	120	58	2,537
2011	12	87	28	4,407
2012	21	96	16 (4)	4,930
2013	13	90	64	4,651
2014	22	89	24	4,695
2015	17	123	6	6,625
2016	12	195	10	8,470
2017	17	240	13	6,462
2018	4	177	4	6,574
2019	7	161	13	11,227
2020	10	327	107	9,563
2021	13	186	1	10,414
2022	14	213	9 (5)	13,393
2023	14	340	12 (4)	10,916
2024	7	244	13 (1)	47,210
2025	11	225	98 (1)	34,506
2026	5	266	10 (2)	—

What is it indicated for?

PhaSeal Protector 20 - Drug Vial Transfer Adapter The Protector 20 is fitted to the drug vial and is used as a docking station between the drug vial for the parenteral drug and Injector Luer. In addition the Protector 20 equilibrates the pressure difference which occurs when fluid or air is added or removed from the drug vial. Liquid transfer takes place through tightly fitting elastomeric membranes to minimize exposure to potentially hazardous drug…

Read the full statement (237 words)

PhaSeal Protector 20 - Drug Vial Transfer Adapter

The Protector 20 is fitted to the drug vial and is used as a docking station between the drug vial for the parenteral drug and Injector Luer. In addition the Protector 20 equilibrates the pressure difference which occurs when fluid or air is added or removed from the drug vial. Liquid transfer takes place through tightly fitting elastomeric membranes to minimize exposure to potentially hazardous drug aerosols and spills that can occur during the reconstitution, administration and disposal processes.

PhaSeal Injector Luer — Drug Transfer Needle Device

The Injector Luer has an encapsulated cannula that is permanently locked onto a syringe using a Luer fitting. Sealed transfer of diluent, drug or air, between the single-use syringe and the various components in the system can be made via the Injector Luer in both the preparation and administration phases.

PhaSeal Connector Luer-Lock — Luer Lock Device

The Connector Luer Lock ensures a sealed connection between the single-use syringe and Injector Luer and the patient’s IV line. With the help of the Connector Luer Lock, injections can be made without drug spillage.

PhaSeal Infusion Set - Intravascular Administration Set

The Infusion Set is a non-vented infusion device that has a built-in connector to be used as a way of making additions of parenteral drugs to infusion fluids in a closed system. The Infusion Set may be used to administer the infusion fluid.

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

https://510kreport.com/device/K972527 · printed Nov 6, 2026

Cite this page

510(k) Report. “K972527: Phaseal, System for Sealed Handling of Chemotherapeutic Agents.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972527

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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